Study Data Extracts Versioning
24R2 Version & earlier
With Study Data Extract versioning, you can choose which version of the Study Data Extract job that you want to run. Each version determines which files will be included in the extract and which version of the CSVs will be used. Columns may have been added, removed, or changed between versions. Columns included in the current version (25R1) can be found here. Columns included in the previous versions (24R3, 24R2, 24R1, 23R3, 23R2, 23R1, 22R3, 22R2, 22R1, 21R3, 21R2) are detailed below.
Jobs scheduled prior to the 25R1 release will be stamped with the 24R3 version of the SDE and still run that version. If you edit the scheduled job by opening the Edit Job dialog, you will see the latest version defaulted in the SDE Version dropdown. Saving this job configuration will update the scheduled job to the newest SDE version.
24R3 Version
Clinical Datasets
Each clinical dataset, and each Form (Adverse Events, Concomitant Medications, etc.), contains a set of Key Columns and a set of Clinical Data columns, which are detailed below.
Key Columns
Key Columns contain data to help identify which Form each row is referring to (ex: which Subject, Site, Cycle, or Event that particular form is located in).
The list of Key Columns is as follows:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | This column refers to study_label or study in the API. | |
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | 512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| VISMETHOD | Visit Method | Text | Char | $ | 100 | $400 | This column is only visible if Visit Method is enabled. | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| FORMSTATUS | Form Status | Text | Char | 100 | 400 | |||
| CREATEDT | Datetime Form Created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTSUBMITDT | Datetime Form First Submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | This field will only be populated for new studies created after 23R3. |
| LASTSUBMITDT | Datetime Form Last Submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| DLASTMOD | Datetime of last data change (UTC). This field is derived by taking the most recent datetime from all of the items' value_modified_date__v on the form. | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Datetime columns can be separated into two separate Date and Time columns. |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| IGGUID | Internal Vault ID (item groups) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| FORMILB | Intentionally Left Blank | Boolean | Char | $ | 5 | $20 | ||
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (Form Link ItemDef Name)_DEF | [Form Link Item Label] Definition | Text | Char | $ | 200 | $800 | If Item to Form Linking is enabled. Format of the cell value: Form Label that is linked to the item. The Form Sequence (#X) is included if the form is repeating. | |
| (Form Link ItemDef Name)_LINKEDFORMID | [Form Link Item Label] Linked Form ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled. | |
| (Form Link ItemDef Name)_LINKID | [Form Link Item Label] Link ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled. | |
| LINKEDTO 1 | Links to other forms | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| ITEMLINKEDTO 2 | Item Linked To | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| LINKEDITEM | Linked Item | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| (ITEMNAME) | (Item Label) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_UTC | (Item Label)_UTC | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_USER | (Item Label)_User | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
|
1 This column displays in the following format: 2 This column displays in the following format: |
||||||||
This format shows up to 3 items on the form, up to the maximum character limit.
Clinical Data
After the Key Columns, the system will insert Clinical Data columns, with each column representing an item on the Form.
Clinical Data Item Headers use the item names or external ID defined in Studio. Some items can be associated with more than one column, depending on their data type:
- Codelists are split into two columns:
- ITEMNAME: this column contains the codelist code
- ITEMNAME_D: this column contains the codelist decode or label
- Units are split into four columns:
- ITEMNAME: this column contains the value entered in the item
- ITEMNAME_U: this column contains the unit entered in the item
- ITEMNAME_TRANS: this column contains the “translated” item value, which is the value that was entered that has been converted to the standard unit
- ITEMNAME_TRANSU: this column contains the standard unit
- Datetimes are split into three columns:
- ITEMNAME: this column contains the datetime value entered (site’s timezone)
- ITEMNAME_UTC: this column contains the datetime value converted to UTC
- ITEMNAME_USER: this column contains the datetime value converted to the timezone of the user running the Study Data Extract
Unknown parts in dates and datetimes are represented by UN in ISO format:
- For a date: 2021-UN-UN
- For a datetime: 2021-UN-TUN:UN:UN.UNKZ
You can choose from the following Clinical Data options:
| Option | Description |
|---|---|
| Use Item External ID instead of Item Name for column headers | Replaces the column headers in the clinical datasets (which currently use the Item Name) with the Item External ID configured in Studio |
| Include Separate Date and Time columns for Datetime items | Creates two additional columns with the postfixes (Item)_DT and (Item)_TM for the Date and Time of the Datetime item |
| Include forms Intentionally Left Blank | Creates a column in the clinical datasets called FORMILB that indicates whether the form has been marked Intentionally Left Blank in clinical datasets (default behavior is to skip rows) |
| Exclude blank forms | Excludes forms whose status = "Blank" in the clinical datasets. Note that these forms will still appear in the SYS_FORM dataset |
Casebook Versions
All casebook versions are displayed in Study Data Extracts, so items that were deleted from the schedule in subsequent casebook versions will still appear in Clinical Datasets. This inclusion guarantees that all data is extracted, even if certain subjects were kept on a previous casebook version.
The Study Data Extract job first adds columns for all items that are present in Casebook Version 1 before adding columns for any items that may have been added in subsequent casebook versions to create the Study Data Extract file.
Lab Columns
Each form configured with Local Labs contains certain columns that are dynamically added after the LASTRUN column for lab items. Refer to the table below for a complete list of columns.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | 128 | $512 | |||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | :vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| DLASTMOD | Datetime of last data change (UTC) | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| IGGUID | Internal Vault ID (Item Groups) | Text | Char | $ | 15 | $60 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| LBDTC | Collection Date Time | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBDTC_UTC | Collection Date Time_UTC | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBDTC_USER | Collection Date Time_USER | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBDTC_RAW | Collection Datetime_RAW | Datetime | Char | $ | 64 | $256 | ||
| LBLOC | Lab Location* | Text | Char | $ | 128 | $512 | ||
| LBAGE | Age | Integer | Num | 14 | 8 | |||
| LBAGE_U | Age_U | Text | Char | 128 | $512 | |||
| LBAGE_TRANS | Age_TRANS | Integer | Num | 14 | 8 | |||
| LBAGE_TRANSU | Age_TRANSU | Text | Char | $ | 128 | $512 | ||
| LBTEST | Lab Test | Text | Char | $ | 128 | $512 | ||
| LABMODIFIER | Lab Modifier | Text | Char | $ | 128 | $512 | Visible for Studies using Global (Versionless) Labs if at least one analyte definition has Lab Modifiers configured. | |
| LABMODIFIER_D | Lab Modifier_D | Text | Char | $ | 256 | $1024 | Visible for Studies using Global (Versionless) Labs if at least one analyte definition has Lab Modifiers configured. | |
| LBORRES | Lab Result | Text, Float, or Integer | Char or Num | $ | 1500 or 14 | $6000 or 8 | Data type may be float or integer if all cells in that column have the same data type. Note that if the data type is float or integer, the length/SAS length may change to the default for numeric values. | |
| LBORRES_U_D | Lab Result Unit or Decode for Codelists and Units | Text | Char | $ | 1500 | $6000 | Visible for Unit, Number, Codelist, or Text analyte type. | |
| LBORRES_TRANS | Lab Result_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORRES_TRANSU | Lab Result_TRANSU | Text | Char | $ | 1500 | $6000 | ||
| LBORNRLO | Normal Range Lower Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRHI | Normal Range Upper Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRLOHI_U | Normal Range Lower and Upper Limit_U | Text | Char | $ | 1500 | $6000 | ||
| LBORNRLO_TRANS | Normal Range Lower Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRHI_TRANS | Normal Range Upper Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRLOHI_TRANSU | Normal Range Lower and Upper Limit_TRANSU | Text | Char | $ | 1500 | $6000 | ||
| LBOVRDNRLO | Normal Range Override Lower Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDNRHI | Normal Range Override Upper Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDNRLOHI_U | Normal Range Override Lower and Upper Limit_U | Text | Char | $ | 1500 | $6000 | ||
| LBOVRDNRLO_TRANS | Normal Range Override Lower Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDRLOHI_TRANSU | Normal Range Override Lower and Upper Limit_TRANSU | Text | Char | $ | 1500 | $6000 | Data type may be integer if all cells in that column are integers. | |
| LBSTNRC | Normal Value | Text | Char | $ | 1500 | $6000 | For Codelist or Text-type Analytes. | |
| LBSTNRC_D | Normal Value_D | Text | Char | $ | 256 | $1024 | For Codelist-type Analytes. | |
| LBOVRDNRC | Normal Value Override | Text | Char | $ | 1500 | $6000 | For Codelist or Text-type Analytes. | |
| LBOVRDNRC_D | Normal Value Override_D | Text | Char | $ | 256 | $1024 | For Codelist-type Analytes. | |
| LBNRIND | Normal Range Indicator | Text | Char | $ | 1500 | $6000 | ||
| LBCLSIG | Clinical Significance | Text | Char | $ | 1500 | $6000 |
*This field refers to the Lab ID.
The LBDTC, LBLOC, and LBAGE columns are part of the Lab Header that is generated for each lab form. Each column related to a Lab Analyte with a “Unit” type has additional columns for the Unit (appended with _U), the Translated Value (appended with _TRANS), and the Translated Unit (appended with _TRANSU). For example, the Lab Result Unit for Sodium would display in the column header as LBORRES_Sodium_U.
Coding Data
If a form is set up for coding, meaning that a coding configuration has been defined in Studio, coding-related columns will be added after clinical data columns. If there are multiple verbatims set up in a form, the system will add a set of coding columns for each verbatim configured. If the same item in different item groups is configured for coding, the system will add “itemgroup.item” to each column header to indicate which set of columns belongs to which verbatim. Note that you need the View Code permission to view coding columns in the SDE.
List of coding columns for MedDRA:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| SOC | SOC | Text | Char | $ | 1500 | $6000 | |
| SOCID | SOC Code | Text | Char | $ | 1500 | $6000 | |
| HLGT | HLGT | Text | Char | $ | 1500 | $6000 | |
| HLGTID | HLGT Code | Text | Char | $ | 1500 | $6000 | |
| HLT | HLT | Text | Char | $ | 1500 | $6000 | |
| HLTID | HLT Code | Text | Char | $ | 1500 | $6000 | |
| PT | PT | Text | Char | $ | 1500 | $6000 | |
| PTID | PT Code | Text | Char | $ | 1500 | $6000 | |
| LLT | LLT | Text | Char | $ | 1500 | $6000 | |
| LLTID | LLT Code | Text | Char | $ | 1500 | $6000 | |
| PRIMPATH | Primary Path | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
List of coding columns for WHODrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| ATC1 | ATC1 | Text | Char | $ | 1500 | $6000 | |
| ATC1CD | ATC1 Code | Text | Char | $ | 1500 | $6000 | |
| ATC2 | ATC2 | Text | Char | $ | 1500 | $6000 | |
| ATC2CD | ATC2 Code | Text | Char | $ | 1500 | $6000 | |
| ATC3 | ATC3 | Text | Char | $ | 1500 | $6000 | |
| ATC3CD | ATC3 Code | Text | Char | $ | 1500 | $6000 | |
| ATC4 | ATC4 | Text | Char | $ | 1500 | $6000 | |
| ATC4CD | ATC4 Code | Text | Char | $ | 1500 | $6000 | |
| PREFNAME | Preferred Name | Text | Char | $ | 1500 | $6000 | |
| PREFCODE | Preferred Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| PREFBASE | Preferred Base Code | Text | Char | $ | 1500 | $6000 | |
| PREFLABEL | Preferred Base | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
List of coding columns for JDrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| GDRUGNAME | Generic Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT1 | Drug Code Category 1 | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT2 | Drug Code Category 2 | Text | Char | $ | 1500 | $6000 | |
| USECAT1 | Use Category 1 | Text | Char | $ | 1500 | $6000 | |
| USECAT2 | Use Category 2 | Text | Char | $ | 1500 | $6000 | |
| MANNAME | Manufacturer Name | Text | Char | $ | 1500 | $6000 | |
| MANCODE | Manufacturer Code | Text | Char | $ | 1500 | $6000 | |
| MAINTFLG | Maintenance Flag | Text | Char | $ | 1500 | $6000 | |
| MAINTDT | Maintenance Date | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
Definitions File
The Study Data Extract ZIP file contains a definition file, which is a listing of all columns across all datasets included in the extract.
List of columns included in the Definitions file:
| Column Header | Data |
|---|---|
| Dataset Name | Name of the dataset |
| Column | Name of the column |
| Type | Item type for clinical data items |
| SAS Type | SAS type of the column |
| SAS Informat | SAS informat applied |
| SAS Format | SAS format applied |
| Length | Length in characters |
| SAS Length | SAS length in bytes |
| Label | SAS Label of the column |
System Datasets
Along with clinical datasets, the Study Data Extract file contains several system datasets that contain operational data and metrics.
SYS_SITE
The SYS_SITE dataset lists all sites for the selected study.
List of SYS_SITE columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Study Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SITENAME | Study Site Name | Text | Char | $ | 128 | $512 | ||
| INVNAME | Principal Investigator | Text | Char | $ | 128 | $512 | ||
| CASEBDEF | Casebook Version | Integer | Num | 14 | 8 | |||
| STATUS | Site Status | Text | Char | $ | 100 | $400 | ||
| TIMEZONE | Timezone of the Site | Text | Char | $ | 100 | $400 | ||
| BULKCASEBOOKSIGNATURE | Bulk Casebook Signature | Boolean | Char | $ | 5 | $20.00 | ||
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_SUB
The SYS_SUB dataset lists all subjects for the selected study.
List of SYS_SUB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| IXRSID | Subject IXRS ID | Text | Char | $ | 255 | $1020 | This column refers to an external Subject ID that may be set through API or Integration. | |
| CASEBDEF | Casebook Version | Integer | Num | 14 | 8 | |||
| STATUS | Status of the Subject/Casebook | Text | Char | $ | 100 | $400 | ||
| SDVPLAN | SDV Plan | Text | Char | $ | 128 | $512 | ||
| DMRPLAN | DMR Plan | Text | Char | $ | 128 | $512 | ||
| FROZEN | Subject Frozen | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| LOCKED | Subject Locked | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| SIGNED | Subject Signed | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| GUID | Internal Vault ID of the subject | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTMODDT | Subject Last Modified Datetime | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LATESTARM | Latest Arm | Text | Char | $ | 128 | $512 | ||
| LATESTCOHORT | Latest Cohort | Text | Char | $ | 128 | $512 | ||
| LATEST SUBSTUDY | Latest Substudy | Text | Char | $ | 128 | $512 | ||
| CNSNTDT | Initial Consent Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| SCRDDT | Screened date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| SCRFAILDT | Screen failed date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ENRDDT | Enrolled date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| RDMDDT | Randomized date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| STARTTRTDT | Started Treatment Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ENDTRTDT | End of treatment date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| WTHDRWNDT | Withdrawn date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| STARTFLLWUPDT | Started Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| LOSTFLLWUPDT | Lost to Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| CMPLTDT | End of study date | Date | Num | : vdate. | DATE9. | 14 | 8 |
SYS_EVT
The SYS_EVT dataset lists all events as well as event dates and status for the selected study.
List of SYS_EVT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9 | 14 | 8 | |
| VISMETHOD | Visit Method | Text | Char | $ | 100 | $400 | This column is only visible if Visit Method is enabled. | |
| PLANNEDDT | Planned Date | Date | Num | : vdate. | DATE9 | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| LASTMODDAT | Last modified date/time of the event date (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CASEBDEF | Casebook Version | Integer | Num | $ | 14 | 8 | ||
| STATUS | Status of the event/visit | Text | Char | $ | 100 | $400 | ||
| LASTREAS | Last change reason | Text | Char | $ | 255 | $1020 | ||
| WINSTAT | Scheduled Window Status | Text | Char | $ | 32 | $128 | ||
| DAYSOW | Days Outside Window | Integer | Num | 14 | 8 | |||
| EXPFORMS | Expected Number of Forms | Integer | Num | 14 | 8 | |||
| FORMEOD | Number of days past due when one or more forms is not yet complete | Integer | Num | 14 | 8 | |||
| EVFROZEN | Event Frozen | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| EVFREEZEDT | Event Frozen Datetime | Date | Num | : vdate. | DATETIME22.3 | 14 | 8 | Populated for Data Model 2 studies only. |
| EVLOCKED | Event Locked | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| EVLOCKDT | Event Locked Datetime | Date | Num | : vdate. | DATETIME22.3 | 14 | 8 | Populated for Data Model 2 studies only. |
| EVSIGNED | Event Signed | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| EVSIGNDT | Event Signed Datetime | Date | Num | : vdate. | DATETIME22.3 | 14 | 8 | Populated for Data Model 2 studies only. |
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_FORM
The SYS_FORM dataset lists all forms for the selected study, including forms Intentionally Left Blank as well as review statuses, freeze and lock statuses, and additional metrics.
List of SYS_FORM columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| STATUS | Form Status | Text | Char | $ | 100 | $400 | ||
| CREATEDT | Datetime form created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTSUBMITDT | Datetime form first submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | This field will only be populated for new studies created after 23R3. |
| LASTSUBMITDT | Datetime form last submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Number of times form was submitted | Integer | Num | 14 | 8 | |||
| SDVOVRPLAN | SDV Override Plan | Text | Char | $ | 128 | $512 | Populated for Data Model 2 studies only. | |
| SDVREQ | SDV Required | Boolean | Char | $ | 5 | $20 | Not supported for SDV rollup V1 studies, will be blank | |
| SDVCOMP | SDV Complete | Boolean | Char | $ | 5 | $20 | Populated for SDV Rollup v2 studies only. | |
| SDVDT | Datetime considered SDV complete (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTSDVDT | Datetime Form First SDV Complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| SDVLAST | Datetime of last SDV modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TOSDV | Days from submit to SDV | Float | Num | 14 | 8 | |||
| DMROVRPLAN | DMR Override Plan | Text | Char | $ | 128 | $512 | Populated for Data Model 2 studies only. | |
| DMRREQ | DMR Required | Boolean | Char | $ | 5 | $20 | Not supported for SDV rollup V1 studies, will be blank | |
| DMRCOMP | DMR Complete | Boolean | Char | $ | 5 | $20 | Populated for SDV Rollup v2 studies only. | |
| DMRDT | Datetime considered DMR complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTDMRDT | Datetime Form First DMR Complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| DMRLAST | Datetime of last DMR modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TODMR | Days from submit to DMR | Float | Num | 14 | 8 | |||
| FROZEN | Form Frozen | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| FREEZEDT | Datetime frozen (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOFREEZE | Days from submit to freeze | Float | Num | 14 | 8 | |||
| LOCKED | Form Locked | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| LOCKDT | Datetime locked (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOLOCK | Days from submit to lock | Float | Num | 14 | 8 | |||
| SIGNED | Form Signed | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| SIGNDT | Datetime signed (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LSTSGNDT | Last Signature Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOSIGN | Days from submit to sign | Float | Num | 14 | 8 | |||
| EDT_SUBM | Days from event date (of form) to submit date | Float | Num | 14 | 8 | |||
| ILB | Intentionally Left Blank | Boolean | Char | $ | 5 | $20 | ||
| ILBREAS | Reason for Intentionally Left Blank | Text | Char | $ | 255 | $1020 | ||
| GUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_Q
The SYS_Q dataset lists all queries for the selected study, along with some query metrics. Only the first query message is listed in this dataset. The full list of query messages (first message, answers, etc.) is included in the SYS_QT dataset.
List of SYS_Q columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | 512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGROUPDEF | Item Group Definition Name | Text | Char | $ | 128 | 512 | ||
| IGSEQ | Item group sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | 128 | $512 | |||
| QUERYID | Query ID | Text | Char | $ | 128 | $512 | ||
| STATUS | Query status | Text | Char | $ | 100 | $400 | Includes Open, Answered, and Closed queries. | |
| RESTRICTED | Query Restricted | Boolean | Char | 5 | $20 | Visible if "Include Restricted Data" is selected in SDE Version 23R1. | ||
| MANUAL | Manual query | Boolean | Char | $ | 5 | $20 | ||
| RULEID | Rule name | Text | Char | $ | 128 | $512 | ||
| TRIGID | Trigger name | Text | Char | $ | 128 | $512 | ||
| QTEXT | Initial query text/message | Text | Char | $ | 500 | $2000 | ||
| QTEXTBASE | Initial query text/message in the user’s language | Text | Char | $ | 500 | $2000 | Will be populated in SDE Version 24R3. May show as blank in some cases. | |
| QTEXTENG | Initial query text/message in English | Text | Char | $ | 500 | $2000 | ||
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created by | Text | Char | $ | 201 | $804 | ||
| LASTCLOSEDDT | Query Last Closed Date | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| QUERYTEAM | Query team | Text | Char | $ | 50 | $200 | ||
| QTFRESP | Time to first response (days) | Float | Num | 14 | 8 | Only populated when there's a First Response Date and the query has a status of "Answered." | ||
| QAGE | Query Age (days) | Float | Num | 14 | 8 | |||
| QCHGDATA | Whether the data changed after query creation (field query attached) | Boolean | Char | $ | 5 | $20 | ||
| QOTOCL | Query open to close (days) | Float | Num | 14 | 8 | |||
| SRCTYPE | Source Type | Text | Char | $ | 30 | $120 | ||
| SRCSYS | Source System Name | Text | Char | $ | 100 | $400 | ||
| SRCUSER | Source User | Text | Char | $ | 100 | $400 | ||
| SRCID | Source ID | Text | Char | $ | 64 | $256 | ||
| GUID | Internal Vault ID of the query | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_QT
The SYS_QT dataset lists all query messages for the selected study.
You can link the content of this file with the SYS_Q dataset using the QUERYID column. There can be multiple SYS_QT records matching one SYS_Q record (i.e. a query in SYS_Q can have multiple query messages in SYS_QT).
List of SYS_QT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| QUERYID | Query ID | Text | Char | $ | 128 | $512 | ||
| STATUS | Query status | Text | Char | $ | 100 | $400 | Includes Open, Answered, Closed, and Reopened queries | |
| RESTRICTED | Query Restricted | Boolean | Char | 5 | $20 | Visible if "Include Restricted Data" is selected in SDE Version 23R1. | ||
| QTEXT | Initial query text/message | Text | Char | $ | 500 | $2000 | ||
| QTEXTBASE | Initial query text/message in the user’s language | Text | Char | $ | 500 | $2000 | Will be populated in SDE Version 24R3. May show as blank in some cases. | |
| QTEXTENG | Initial query text/message in English | Text | Char | $ | 500 | $2000 | Will be populated in SDE Version 24R3. May show as blank in some cases. | |
| TEXTDT | Text/Message Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TEXTBY | Text/Message By | Text | Char | $ | 201 | $1804 | ||
| QUERYTEAM | Query team | Text | Char | $ | 50 | $200 | ||
| SRCTYPE | Message Source Type | Text | Char | $ | 30 | $120 | ||
| SRCSYS | Message Source System Name | Text | Char | $ | 100 | $400 | ||
| SRCUSER | Message Source User | Text | Char | $ | 100 | $400 | ||
| SRCID | Message Source ID | Text | Char | $ | 64 | $256 | ||
| GUID | Internal Vault ID of the query message | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ILB
The SYS_ILB dataset lists all items that have been marked Intentionally Left Blank in the selected study.
List of SYS_ILB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition Name | Text | Char | 128 | 512 | |||
| IGROUPEID | Item Group External ID | Text | Char | 128 | 512 | |||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | $ | 128 | $512 | ||
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | Visible if Local Labs is enabled | |
| ILBREAS | Reason for intentionally left blank | Text | Char | $ | 255 | $1020 | ||
| GUID | Internal Vault ID of the item/field | Text | Char | $ | 100 | $400 | For HVO objects (item2__v), the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LINKS
The SYS_LINKS dataset lists all forms that belong to a form link in the selected study. Forms that are linked together will share the same link ID, which will display in the GUID column. The form unique identifier (FGUID) can then be used to identify a specific form and access its data.
List of SYS_LINKS columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Description |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form external ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | Only visible if Form Linking is enabled. | |
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | Only visible if Form Linking is enabled. | |
| ITEMEID | Item External ID | Text | Char | 128 | $512 | Only visible if Form Linking is enabled. | ||
| FORMCREATEDDT | Form Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LINKCREATEDDT | Link Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created by | Text | Char | $ | 201 | $804 | ||
| FGUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| GUID | Internal Link ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASM
The SYS_ASM dataset lists the following information about assessments, if assessments are configured for a Study.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| SOURCEF | Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| SOURCEFEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| ASMNAME | Assessment Name | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| ASMEID | Assessment External ID | Text | Char | $ | 128 | $512 | ||
| ASMTYPE | Assessment Type | Text | Char | $ | 128 | $512 | ||
| REASSESSMENT | Reassessment | Boolean | Char | $ | 5 | $20 | ||
| SOURCEF | Source Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| STATUS | Status of Assessment | Text | Char | $ | 100 | $400 | ||
| SOURCEFRESTRICTED | Source Form Restricted | Boolean | Char | $ | 5 | $20 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| COMPDT | Completed Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Submit Count | Integer | Num | 14 | 8 | |||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| GUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| FGUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASMR
The SYS_ASMR dataset lists questions and answers for all assessments in a Study, if assessments are configured.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| SOURCEF | Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| SOURCEFEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| QUESNUM | Question Number | Integer | Num | 14 | 8 | |||
| ASMNAME | Assessment Name | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| ASMEID | Assessment External ID | Text | Char | $ | 128 | $512 | ||
| QUESTEXT | Question Text | Text | Char | $ | 128 | $512 | ||
| QUESTEXTDEF | Question Text Definition | Text | Char | $ | 128 | $512 | ||
| QUESEID | Question External ID | Text | Char | $ | 128 | $512 | ||
| QUESANS | Question Answer | Text | Char | $ | 1500 | $6000 | ||
| SOURCEFRESTRICTED | Source Form Restricted | Boolean | Char | $ | 5 | $20 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| AGUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_PD
The SYS_PD dataset lists the following Protocol Deviations information, if Protocol Deviations is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| PDID | Protocol Deviation Identifier | Text | Char | $ | 128 | $512 | ||
| PDSUM | Protocol Deviation Summary | Text | Char | $ | 250 | $1000 | ||
| PDDAT | Date of Deviation | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDDATID | Date Identified | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDCAT | Category | Text | Char | $ | 128 | $512 | ||
| PDCATLABEL | Category Label | Text | Char | $ | 128 | $512 | ||
| PDSUBCAT | Subcategory | Text | Char | $ | 128 | $512 | ||
| PDSUBCATLABEL | Subcategory Label | Text | Char | $ | 128 | $512 | ||
| PDSEV | Severity | Text | Char | $ | 128 | $512 | ||
| PDSEVLABEL | Severity Label | Text | Char | $ | 128 | $512 | ||
| PDDESC | Description | Text | Char | $ | 500 | $2000 | ||
| PDSTATUS | Protocol Deviation Status | Text | Char | $ | 100 | $400 | ||
| PDRES | Protocol Deviation Resolution | Text | Char | $ | 500 | $2000 | ||
| PDRULE | Protocol Deviation Rule | Text | Char | $ | 128 | $512 | ||
| RESTRICTED | Protocol Deviation Restricted | Boolean | Char | 5 | $20 | |||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | 128 | $512 | |||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| USERMODDT | User Modified Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| USERMODB | User Modified By | Text | Char | $ | 201 | $804 | ||
| LASTREAS | Last Change Reason | Text | Char | $ | 255 | $1020 | ||
| INACBYSYS | Inactivated by System | Boolean | Char | $ | 5 | $20 | ||
| LASTINACDT | Last Inactivated Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID of Form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| PDGUID | Internal Vault ID of Protocol Deviation | Text | Char | $ | 15 | $60 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_RAND
The SYS_RAND dataset lists the following Randomization information, if Randomization is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITE | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| RANDSTATUS | Randomization Status | Text | Char | $ | 100 | $400 | ||
| RANDID | Randomization ID | Text | Char | $ | 128 | $512 | ||
| TREATMENTNAME* | Treatment Name | Text | Char | $ | 128 | $512 | ||
| TREATMENTLABEL* | Treatment Label | Text | Char | $ | 1500 | $6000 | ||
| TREATMENTARM* | Treatment Arm | Text | Char | $ | 128 | $512 | Visible if "Include Randomization Treatment" is selected in SDE Version 22R1 or later | |
| RANDSTRATA | Strata Group | Text | Char | $ | 128 | $512 | ||
| RANDBY | Randomized By | Text | Char | $ | 201 | $804 | ||
| RANDDAT | Randomized Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| RANDFILE | Randomization File Label | Text | Char | $ | 128 | $512 | ||
| RANDFILEDAT | Randomization File Upload Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
*These columns are only available for unmasked studies with Randomization enabled and users with the View Unmasked Data and View Randomization Enrollment permissions. To include these columns, check the Include Randomization Treatment box in the New Job dialog. Note that you can’t download SDE files from users with the View Randomization Enrollment permission if the Include Randomization Treatment checkbox is not visible to you in the SDE job dialog.
SYS_LABRANGES
The SYS_LABRANGES dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | |
| LABLOC | Lab Location | Text | Char | $ | 128 | $512 | |
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | |
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 128 | $512 | |
| LABREFRSTATUS | Lab Reference Range Status | Text | Char | $ | 100 | $400 | |
| LABTESTCODE | Test Code | Text | Char | $ | 128 | $512 | |
| LABSEX | Sex | Text | Char | $ | 128 | $512 | |
| LABLOWERAGE | Lower Age | Integer | Num | 14 | 8 | ||
| LABUPPERAGE | Upper Age | Integer | Num | 14 | 8 | ||
| LABAGEUNIT | Age Unit | Text | Char | $ | 128 | $512 | |
| LABFEMCYCLE | Female Cycle | Text | Char | $ | 128 | $512 | |
| LABLNORMAL | Lower Normal | Float | Num | 14 | 8 | ||
| LABUNORMAL | Upper Normal | Float | Num | 14 | 8 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 128 | $512 | |
| LABMEASUNITLABEL | Measurement Unit Label | Text | Char | $ | 128 | $512 | |
| LABCODENORM | Codelist Normal | Text | Char | $ | 128 | $512 | |
| LABTEXTNORM | Text Normal | Text | Char | $ | 3000 | $12000 | |
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | $20 | |
| LABFROMDT | Effective From Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABTODT | Effective To Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABDESCR | Description | Text | Char | $ | 500 | $2000 | |
| LABSPECTYPE | Specimen Type | Text | Char | $ | 128 | $512 | |
| LABTESTMET | Testing Method | Text | Char | $ | 128 | $512 | |
| CREATB | Created By | Text | Char | $ | 201 | $804 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LABLOC
The SYS_LABLOC dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | ||
| LABLOC | Lab Location | Text | Char | $ | 128 | $512 | ||
| LABLOCSTATUS | Lab Location Status | Text | Char | $ | 100 | $400 | ||
| LABAPPROVED | Approved Lab Location | Text | Char | $ | 128 | $512 | ||
| LABADDRESS | Lab Address | Text | Char | $ | 500 | $2000 | ||
| LABCOUNTRY | Lab Country | Text | Char | $ | 128 | $512 | ||
| LABCONTACT | Lab Contact Name | Text | Char | $ | 128 | $512 | ||
| LABCONTITLE | Lab Contact Title | Text | Char | $ | 128 | $512 | ||
| LABTEL | Lab Telephone | Text | Char | $ | 40 | $160 | ||
| LABFAX | Lab Fax | Text | Char | $ | 40 | $160 | ||
| LABPRIMEMAIL | Lab Primary Email | Text | Char | $ | 80 | $320 | ||
| LABSECMAIL | Lab Secondary Email | Text | Char | $ | 80 | $320 | ||
| LABSTATUS | Lab Status | Text | Char | $ | 100 | $400 | ||
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ANALYTES
The SYS_ANALYTES dataset lists the following Labs analyte information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | ||
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 128 | $512 | ||
| LABDESCR | Description | Text | Char | $ | 500 | $2000 | ||
| LABDATATYPE | Data Type | Text | Char | $ | 100 | $400 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 128 | $512 | ||
| LABCODELIST | Codelist | Text | Char | $ | 128 | $512 | ||
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | $20 | ||
| LABSPECTYPE | Specimen Type | Text | Char | $ | 128 | $512 | ||
| LABLEN | Length | Integer | Num | 14 | 8 | |||
| LABPREC | Precision | Integer | Num | 14 | 8 | |||
| LABSYSMANAGED | System Managed | Boolean | Char | $ | 5 | $20 | ||
| LABTESTMET | Testing Method | Text | Char | $ | 128 | $512 | ||
| LABLOINC | LOINC Code | Text | Char | $ | 128 | $512 | ||
| LABSDTMNM | SDTM Name | Text | Char | $ | 255 | $1020 | ||
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
24R2 Version
Clinical Datasets
Each clinical dataset, and each Form (Adverse Events, Concomitant Medications, etc.), contains a set of Key Columns and a set of Clinical Data columns, which are detailed below.
Key Columns
Key Columns contain data to help identify which Form each row is referring to (ex: which Subject, Site, Cycle, or Event that particular form is located in).
The list of Key Columns is as follows:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | This column refers to study_label or study in the API. | |
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | 512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| VISMETHOD | Visit Method | Text | Char | $ | 100 | $400 | This column is only visible if Visit Method is enabled. | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| FORMSTATUS | Form Status | Text | Char | 100 | 400 | |||
| CREATEDT | Datetime Form Created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTSUBMITDT | Datetime Form First Submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | This field will only be populated for new studies created after 23R3. |
| LASTSUBMITDT | Datetime Form Last Submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| DLASTMOD | Datetime of last data change (UTC). This field is derived by taking the most recent datetime from all of the items' value_modified_date__v on the form. | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Datetime columns can be separated into two separate Date and Time columns. |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| IGGUID | Internal Vault ID (item groups) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| FORMILB | Intentionally Left Blank | Boolean | Char | $ | 5 | $20 | ||
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (Form Link ItemDef Name)_DEF | [Form Link Item Label] Definition | Text | Char | $ | 200 | $800 | If Item to Form Linking is enabled. Format of the cell value: Form Label that is linked to the item. The Form Sequence (#X) is included if the form is repeating. | |
| (Form Link ItemDef Name)_LINKEDFORMID | [Form Link Item Label] Linked Form ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled. | |
| (Form Link ItemDef Name)_LINKID | [Form Link Item Label] Link ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled. | |
| LINKEDTO 1 | Links to other forms | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| ITEMLINKEDTO 2 | Item Linked To | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| LINKEDITEM | Linked Item | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| (ITEMNAME) | (Item Label) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_UTC | (Item Label)_UTC | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_USER | (Item Label)_User | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
|
1 This column displays in the following format: 2 This column displays in the following format: |
||||||||
This format shows up to 3 items on the form, up to the maximum character limit.
Clinical Data
After the Key Columns, the system will insert Clinical Data columns, with each column representing an item on the Form.
Clinical Data Item Headers use the item names or external ID defined in Studio. Some items can be associated with more than one column, depending on their data type:
- Codelists are split into two columns:
- ITEMNAME: this column contains the codelist code
- ITEMNAME_D: this column contains the codelist decode or label
- Units are split into four columns:
- ITEMNAME: this column contains the value entered in the item
- ITEMNAME_U: this column contains the unit entered in the item
- ITEMNAME_TRANS: this column contains the “translated” item value, which is the value that was entered that has been converted to the standard unit
- ITEMNAME_TRANSU: this column contains the standard unit
- Datetimes are split into three columns:
- ITEMNAME: this column contains the datetime value entered (site’s timezone)
- ITEMNAME_UTC: this column contains the datetime value converted to UTC
- ITEMNAME_USER: this column contains the datetime value converted to the timezone of the user running the Study Data Extract
Unknown parts in dates and datetimes are represented by UN in ISO format:
- For a date: 2021-UN-UN
- For a datetime: 2021-UN-TUN:UN:UN.UNKZ
You can choose from the following Clinical Data options:
| Option | Description |
|---|---|
| Use Item External ID instead of Item Name for column headers | Replaces the column headers in the clinical datasets (which currently use the Item Name) with the Item External ID configured in Studio |
| Include Separate Date and Time columns for Datetime items | Creates two additional columns with the postfixes (Item)_DT and (Item)_TM for the Date and Time of the Datetime item |
| Include forms Intentionally Left Blank | Creates a column in the clinical datasets called FORMILB that indicates whether the form has been marked Intentionally Left Blank in clinical datasets (default behavior is to skip rows) |
| Exclude blank forms | Excludes forms whose status = "Blank" in the clinical datasets. Note that these forms will still appear in the SYS_FORM dataset |
Casebook Versions
All casebook versions are displayed in Study Data Extracts, so items that were deleted from the schedule in subsequent casebook versions will still appear in Clinical Datasets. This inclusion guarantees that all data is extracted, even if certain subjects were kept on a previous casebook version.
The Study Data Extract job first adds columns for all items that are present in Casebook Version 1 before adding columns for any items that may have been added in subsequent casebook versions to create the Study Data Extract file.
Lab Columns
Each form configured with Local Labs contains certain columns that are dynamically added after the LASTRUN column for lab items. Refer to the table below for a complete list of columns.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | 128 | $512 | |||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | :vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| DLASTMOD | Datetime of last data change (UTC) | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| IGGUID | Internal Vault ID (Item Groups) | Text | Char | $ | 15 | $60 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| LBDTC | Collection Date Time | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBDTC_UTC | Collection Date Time_UTC | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBDTC_USER | Collection Date Time_USER | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBLOC | Lab Location* | Text | Char | $ | 128 | $512 | ||
| LBAGE | Age | Integer | Num | 14 | 8 | |||
| LBAGE_U | Age_U | Text | Char | 128 | $512 | |||
| LBAGE_TRANS | Age_TRANS | Integer | Num | 14 | 8 | |||
| LBAGE_TRANSU | Age_TRANSU | Text | Char | $ | 128 | $512 | ||
| LBTEST | Lab Test | Text | Char | $ | 128 | $512 | ||
| LABMODIFIER | Lab Modifier | Text | Char | $ | 128 | $512 | Visible for Studies using Global (Versionless) Labs if at least one analyte definition has Lab Modifiers configured. | |
| LABMODIFIER_D | Lab Modifier_D | Text | Char | $ | 256 | $1024 | Visible for Studies using Global (Versionless) Labs if at least one analyte definition has Lab Modifiers configured. | |
| LBORRES | Lab Result | Text, Float, or Integer | Char or Num | $ | 1500 or 14 | $6000 or 8 | Data type may be float or integer if all cells in that column have the same data type. Note that if the data type is float or integer, the length/SAS length may change to the default for numeric values. | |
| LBORRES_U_D | Lab Result Unit or Decode for Codelists and Units | Text | Char | $ | 1500 | $6000 | Visible for Unit, Number, Codelist, or Text analyte type. | |
| LBORRES_TRANS | Lab Result_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORRES_TRANSU | Lab Result_TRANSU | Text | Char | $ | 1500 | $6000 | ||
| LBORNRLO | Normal Range Lower Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRHI | Normal Range Upper Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRLOHI_U | Normal Range Lower and Upper Limit_U | Text | Char | $ | 1500 | $6000 | ||
| LBORNRLO_TRANS | Normal Range Lower Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRHI_TRANS | Normal Range Upper Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRLOHI_TRANSU | Normal Range Lower and Upper Limit_TRANSU | Text | Char | $ | 1500 | $6000 | ||
| LBOVRDNRLO | Normal Range Override Lower Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDNRHI | Normal Range Override Upper Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDNRLOHI_U | Normal Range Override Lower and Upper Limit_U | Text | Char | $ | 1500 | $6000 | ||
| LBOVRDNRLO_TRANS | Normal Range Override Lower Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDRLOHI_TRANSU | Normal Range Override Lower and Upper Limit_TRANSU | Text | Char | $ | 1500 | $6000 | Data type may be integer if all cells in that column are integers. | |
| LBSTNRC | Normal Value | Text | Char | $ | 1500 | $6000 | For Codelist or Text-type Analytes. | |
| LBSTNRC_D | Normal Value_D | Text | Char | $ | 256 | $1024 | For Codelist-type Analytes. | |
| LBOVRDNRC | Normal Value Override | Text | Char | $ | 1500 | $6000 | For Codelist or Text-type Analytes. | |
| LBOVRDNRC_D | Normal Value Override_D | Text | Char | $ | 256 | $1024 | For Codelist-type Analytes. | |
| LBNRIND | Normal Range Indicator | Text | Char | $ | 1500 | $6000 | ||
| LBCLSIG | Clinical Significance | Text | Char | $ | 1500 | $6000 |
*This field refers to the Lab ID.
The LBDTC, LBLOC, and LBAGE columns are part of the Lab Header that is generated for each lab form. Each column related to a Lab Analyte with a “Unit” type has additional columns for the Unit (appended with _U), the Translated Value (appended with _TRANS), and the Translated Unit (appended with _TRANSU). For example, the Lab Result Unit for Sodium would display in the column header as LBORRES_Sodium_U.
Coding Data
If a form is set up for coding, meaning that a coding configuration has been defined in Studio, coding-related columns will be added after clinical data columns. If there are multiple verbatims set up in a form, the system will add a set of coding columns for each verbatim configured. If the same item in different item groups is configured for coding, the system will add “itemgroup.item” to each column header to indicate which set of columns belongs to which verbatim. Note that you need the View Code permission to view coding columns in the SDE.
List of coding columns for MedDRA:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| SOC | SOC | Text | Char | $ | 1500 | $6000 | |
| SOCID | SOC Code | Text | Char | $ | 1500 | $6000 | |
| HLGT | HLGT | Text | Char | $ | 1500 | $6000 | |
| HLGTID | HLGT Code | Text | Char | $ | 1500 | $6000 | |
| HLT | HLT | Text | Char | $ | 1500 | $6000 | |
| HLTID | HLT Code | Text | Char | $ | 1500 | $6000 | |
| PT | PT | Text | Char | $ | 1500 | $6000 | |
| PTID | PT Code | Text | Char | $ | 1500 | $6000 | |
| LLT | LLT | Text | Char | $ | 1500 | $6000 | |
| LLTID | LLT Code | Text | Char | $ | 1500 | $6000 | |
| PRIMPATH | Primary Path | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
List of coding columns for WHODrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| ATC1 | ATC1 | Text | Char | $ | 1500 | $6000 | |
| ATC1CD | ATC1 Code | Text | Char | $ | 1500 | $6000 | |
| ATC2 | ATC2 | Text | Char | $ | 1500 | $6000 | |
| ATC2CD | ATC2 Code | Text | Char | $ | 1500 | $6000 | |
| ATC3 | ATC3 | Text | Char | $ | 1500 | $6000 | |
| ATC3CD | ATC3 Code | Text | Char | $ | 1500 | $6000 | |
| ATC4 | ATC4 | Text | Char | $ | 1500 | $6000 | |
| ATC4CD | ATC4 Code | Text | Char | $ | 1500 | $6000 | |
| PREFNAME | Preferred Name | Text | Char | $ | 1500 | $6000 | |
| PREFCODE | Preferred Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| PREFBASE | Preferred Base Code | Text | Char | $ | 1500 | $6000 | |
| PREFLABEL | Preferred Base | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
List of coding columns for JDrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| GDRUGNAME | Generic Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT1 | Drug Code Category 1 | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT2 | Drug Code Category 2 | Text | Char | $ | 1500 | $6000 | |
| USECAT1 | Use Category 1 | Text | Char | $ | 1500 | $6000 | |
| USECAT2 | Use Category 2 | Text | Char | $ | 1500 | $6000 | |
| MANNAME | Manufacturer Name | Text | Char | $ | 1500 | $6000 | |
| MANCODE | Manufacturer Code | Text | Char | $ | 1500 | $6000 | |
| MAINTFLG | Maintenance Flag | Text | Char | $ | 1500 | $6000 | |
| MAINTDT | Maintenance Date | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
Definitions File
The Study Data Extract ZIP file contains a definition file, which is a listing of all columns across all datasets included in the extract.
List of columns included in the Definitions file:
| Column Header | Data |
|---|---|
| Dataset Name | Name of the dataset |
| Column | Name of the column |
| Type | Item type for clinical data items |
| SAS Type | SAS type of the column |
| SAS Informat | SAS informat applied |
| SAS Format | SAS format applied |
| Length | Length in characters |
| SAS Length | SAS length in bytes |
| Label | SAS Label of the column |
System Datasets
Along with clinical datasets, the Study Data Extract file contains several system datasets that contain operational data and metrics.
SYS_SITE
The SYS_SITE dataset lists all sites for the selected study.
List of SYS_SITE columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Study Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SITENAME | Study Site Name | Text | Char | $ | 128 | $512 | ||
| INVNAME | Principal Investigator | Text | Char | $ | 128 | $512 | ||
| CASEBDEF | Casebook Version | Integer | Num | 14 | 8 | |||
| STATUS | Site Status | Text | Char | $ | 100 | $400 | ||
| TIMEZONE | Timezone of the Site | Text | Char | $ | 100 | $400 | ||
| BULKCASEBOOKSIGNATURE | Bulk Casebook Signature | Boolean | Char | $ | 5 | $20.00 | ||
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_SUB
The SYS_SUB dataset lists all subjects for the selected study.
List of SYS_SUB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| IXRSID | Subject IXRS ID | Text | Char | $ | 255 | $1020 | This column refers to an external Subject ID that may be set through API or Integration. | |
| CASEBDEF | Casebook Version | Integer | Num | 14 | 8 | |||
| STATUS | Status of the Subject/Casebook | Text | Char | $ | 100 | $400 | ||
| SDVPLAN | SDV Plan | Text | Char | $ | 128 | $512 | ||
| DMRPLAN | DMR Plan | Text | Char | $ | 128 | $512 | ||
| FROZEN | Subject Frozen | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| LOCKED | Subject Locked | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| SIGNED | Subject Signed | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| GUID | Internal Vault ID of the subject | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTMODDT | Subject Last Modified Datetime | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LATESTARM | Latest Arm | Text | Char | $ | 128 | $512 | ||
| LATESTCOHORT | Latest Cohort | Text | Char | $ | 128 | $512 | ||
| LATEST SUBSTUDY | Latest Substudy | Text | Char | $ | 128 | $512 | ||
| CNSNTDT | Initial Consent Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| SCRDDT | Screened date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| SCRFAILDT | Screen failed date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ENRDDT | Enrolled date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| RDMDDT | Randomized date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| STARTTRTDT | Started Treatment Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ENDTRTDT | End of treatment date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| WTHDRWNDT | Withdrawn date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| STARTFLLWUPDT | Started Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| LOSTFLLWUPDT | Lost to Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| CMPLTDT | End of study date | Date | Num | : vdate. | DATE9. | 14 | 8 |
SYS_EVT
The SYS_EVT dataset lists all events as well as event dates and status for the selected study.
List of SYS_EVT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9 | 14 | 8 | |
| VISMETHOD | Visit Method | Text | Char | $ | 100 | $400 | This column is only visible if Visit Method is enabled. | |
| PLANNEDDT | Planned Date | Date | Num | : vdate. | DATE9 | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| LASTMODDAT | Last modified date/time of the event date (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CASEBDEF | Casebook Version | Integer | Num | $ | 14 | 8 | ||
| STATUS | Status of the event/visit | Text | Char | $ | 100 | $400 | ||
| LASTREAS | Last change reason | Text | Char | $ | 255 | $1020 | ||
| WINSTAT | Scheduled Window Status | Text | Char | $ | 32 | $128 | ||
| DAYSOW | Days Outside Window | Integer | Num | 14 | 8 | |||
| EXPFORMS | Expected Number of Forms | Integer | Num | 14 | 8 | |||
| FORMEOD | Number of days past due when one or more forms is not yet complete | Integer | Num | 14 | 8 | |||
| EVFROZEN | Event Frozen | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| EVFREEZEDT | Event Frozen Datetime | Date | Num | : vdate. | DATETIME22.3 | 14 | 8 | Populated for Data Model 2 studies only. |
| EVLOCKED | Event Locked | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| EVLOCKDT | Event Locked Datetime | Date | Num | : vdate. | DATETIME22.3 | 14 | 8 | Populated for Data Model 2 studies only. |
| EVSIGNED | Event Signed | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| EVSIGNDT | Event Signed Datetime | Date | Num | : vdate. | DATETIME22.3 | 14 | 8 | Populated for Data Model 2 studies only. |
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_FORM
The SYS_FORM dataset lists all forms for the selected study, including forms Intentionally Left Blank as well as review statuses, freeze and lock statuses, and additional metrics.
List of SYS_FORM columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| STATUS | Form Status | Text | Char | $ | 100 | $400 | ||
| CREATEDT | Datetime form created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTSUBMITDT | Datetime form first submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | This field will only be populated for new studies created after 23R3. |
| LASTSUBMITDT | Datetime form last submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Number of times form was submitted | Integer | Num | 14 | 8 | |||
| SDVOVRPLAN | SDV Override Plan | Text | Char | $ | 128 | $512 | Populated for Data Model 2 studies only. | |
| SDVREQ | SDV Required | Boolean | Char | $ | 5 | $20 | Not supported for SDV rollup V1 studies, will be blank | |
| SDVCOMP | SDV Complete | Boolean | Char | $ | 5 | $20 | Populated for SDV Rollup v2 studies only. | |
| SDVDT | Datetime considered SDV complete (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTSDVDT | Datetime Form First SDV Complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| SDVLAST | Datetime of last SDV modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TOSDV | Days from submit to SDV | Float | Num | 14 | 8 | |||
| DMROVRPLAN | DMR Override Plan | Text | Char | $ | 128 | $512 | Populated for Data Model 2 studies only. | |
| DMRREQ | DMR Required | Boolean | Char | $ | 5 | $20 | Not supported for SDV rollup V1 studies, will be blank | |
| DMRCOMP | DMR Complete | Boolean | Char | $ | 5 | $20 | Populated for SDV Rollup v2 studies only. | |
| DMRDT | Datetime considered DMR complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTDMRDT | Datetime Form First DMR Complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| DMRLAST | Datetime of last DMR modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TODMR | Days from submit to DMR | Float | Num | 14 | 8 | |||
| FROZEN | Form Frozen | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| FREEZEDT | Datetime frozen (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOFREEZE | Days from submit to freeze | Float | Num | 14 | 8 | |||
| LOCKED | Form Locked | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| LOCKDT | Datetime locked (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOLOCK | Days from submit to lock | Float | Num | 14 | 8 | |||
| SIGNED | Form Signed | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| SIGNDT | Datetime signed (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LSTSGNDT | Last Signature Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOSIGN | Days from submit to sign | Float | Num | 14 | 8 | |||
| EDT_SUBM | Days from event date (of form) to submit date | Float | Num | 14 | 8 | |||
| ILB | Intentionally Left Blank | Boolean | Char | $ | 5 | $20 | ||
| ILBREAS | Reason for Intentionally Left Blank | Text | Char | $ | 255 | $1020 | ||
| GUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_Q
The SYS_Q dataset lists all queries for the selected study, along with some query metrics. Only the first query message is listed in this dataset. The full list of query messages (first message, answers, etc.) is included in the SYS_QT dataset.
List of SYS_Q columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | 512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGROUPDEF | Item Group Definition Name | Text | Char | $ | 128 | 512 | ||
| IGSEQ | Item group sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | 128 | $512 | |||
| QUERYID | Query ID | Text | Char | $ | 128 | $512 | ||
| STATUS | Query status | Text | Char | $ | 100 | $400 | Includes Open, Answered, and Closed queries. | |
| RESTRICTED | Query Restricted | Boolean | Char | 5 | $20 | Visible if "Include Restricted Data" is selected in SDE Version 23R1. | ||
| MANUAL | Manual query | Boolean | Char | $ | 5 | $20 | ||
| RULEID | Rule name | Text | Char | $ | 128 | $512 | ||
| TRIGID | Trigger name | Text | Char | $ | 128 | $512 | ||
| QTEXT | Initial query text/message | Text | Char | $ | 500 | $2000 | ||
| QTEXTBASE | Initial query text/message in the user’s language | Text | Char | $ | 500 | $2000 | Will be populated in SDE Version 24R3. May show as blank in some cases. | |
| QTEXTENG | Initial query text/message in English | Text | Char | $ | 500 | $2000 | Will be populated in SDE Version 24R3. May show as blank in some cases. | |
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created by | Text | Char | $ | 201 | $804 | ||
| LASTCLOSEDDT | Query Last Closed Date | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| QUERYTEAM | Query team | Text | Char | $ | 50 | $200 | ||
| QTFRESP | Time to first response (days) | Float | Num | 14 | 8 | Only populated when there's a First Response Date and the query has a status of "Answered." | ||
| QAGE | Query Age (days) | Float | Num | 14 | 8 | |||
| QCHGDATA | Whether the data changed after query creation (field query attached) | Boolean | Char | $ | 5 | $20 | ||
| QOTOCL | Query open to close (days) | Float | Num | 14 | 8 | |||
| SRCTYPE | Source Type | Text | Char | $ | 30 | $120 | ||
| SRCSYS | Source System Name | Text | Char | $ | 100 | $400 | ||
| SRCUSER | Source User | Text | Char | $ | 100 | $400 | ||
| SRCID | Source ID | Text | Char | $ | 64 | $256 | ||
| GUID | Internal Vault ID of the query | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_QT
The SYS_QT dataset lists all query messages for the selected study.
You can link the content of this file with the SYS_Q dataset using the QUERYID column. There can be multiple SYS_QT records matching one SYS_Q record (i.e. a query in SYS_Q can have multiple query messages in SYS_QT).
List of SYS_QT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| QUERYID | Query ID | Text | Char | $ | 128 | $512 | ||
| STATUS | Query status | Text | Char | $ | 100 | $400 | Includes Open, Answered, Closed, and Reopened queries | |
| RESTRICTED | Query Restricted | Boolean | Char | 5 | $20 | Visible if "Include Restricted Data" is selected in SDE Version 23R1. | ||
| QTEXT | Initial query text/message | Text | Char | $ | 500 | $2000 | ||
| TEXTDT | Text/Message Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TEXTBY | Text/Message By | Text | Char | $ | 201 | $1804 | ||
| QUERYTEAM | Query team | Text | Char | $ | 50 | $200 | ||
| SRCTYPE | Message Source Type | Text | Char | $ | 30 | $120 | ||
| SRCSYS | Message Source System Name | Text | Char | $ | 100 | $400 | ||
| SRCUSER | Message Source User | Text | Char | $ | 100 | $400 | ||
| SRCID | Message Source ID | Text | Char | $ | 64 | $256 | ||
| GUID | Internal Vault ID of the query message | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ILB
The SYS_ILB dataset lists all items that have been marked Intentionally Left Blank in the selected study.
List of SYS_ILB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition Name | Text | Char | 128 | 512 | |||
| IGROUPEID | Item Group External ID | Text | Char | 128 | 512 | |||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | $ | 128 | $512 | ||
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | Visible if Local Labs is enabled | |
| ILBREAS | Reason for intentionally left blank | Text | Char | $ | 255 | $1020 | ||
| GUID | Internal Vault ID of the item/field | Text | Char | $ | 100 | $400 | For HVO objects (item2__v), the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LINKS
The SYS_LINKS dataset lists all forms that belong to a form link in the selected study. Forms that are linked together will share the same link ID, which will display in the GUID column. The form unique identifier (FGUID) can then be used to identify a specific form and access its data.
List of SYS_LINKS columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Description |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form external ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | Only visible if Form Linking is enabled. | |
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | Only visible if Form Linking is enabled. | |
| ITEMEID | Item External ID | Text | Char | 128 | $512 | Only visible if Form Linking is enabled. | ||
| FORMCREATEDDT | Form Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LINKCREATEDDT | Link Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created by | Text | Char | $ | 201 | $804 | ||
| FGUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| GUID | Internal Link ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASM
The SYS_ASM dataset lists the following information about assessments, if assessments are configured for a Study.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| SOURCEF | Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| SOURCEFEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| ASMNAME | Assessment Name | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| ASMEID | Assessment External ID | Text | Char | $ | 128 | $512 | ||
| ASMTYPE | Assessment Type | Text | Char | $ | 128 | $512 | ||
| REASSESSMENT | Reassessment | Boolean | Char | $ | 5 | $20 | ||
| SOURCEF | Source Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| STATUS | Status of Assessment | Text | Char | $ | 100 | $400 | ||
| SOURCEFRESTRICTED | Source Form Restricted | Boolean | Char | $ | 5 | $20 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| COMPDT | Completed Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Submit Count | Integer | Num | 14 | 8 | |||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| GUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| FGUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASMR
The SYS_ASMR dataset lists questions and answers for all assessments in a Study, if assessments are configured.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| SOURCEF | Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| SOURCEFEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| QUESNUM | Question Number | Integer | Num | 14 | 8 | |||
| ASMNAME | Assessment Name | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| ASMEID | Assessment External ID | Text | Char | $ | 128 | $512 | ||
| QUESTEXT | Question Text | Text | Char | $ | 128 | $512 | ||
| QUESTEXTDEF | Question Text Definition | Text | Char | $ | 128 | $512 | ||
| QUESEID | Question External ID | Text | Char | $ | 128 | $512 | ||
| QUESANS | Question Answer | Text | Char | $ | 1500 | $6000 | ||
| SOURCEFRESTRICTED | Source Form Restricted | Boolean | Char | $ | 5 | $20 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| AGUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_PD
The SYS_PD dataset lists the following Protocol Deviations information, if Protocol Deviations is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| PDID | Protocol Deviation Identifier | Text | Char | $ | 128 | $512 | ||
| PDSUM | Protocol Deviation Summary | Text | Char | $ | 250 | $1000 | ||
| PDDAT | Date of Deviation | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDDATID | Date Identified | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDCAT | Category | Text | Char | $ | 128 | $512 | ||
| PDCATLABEL | Category Label | Text | Char | $ | 128 | $512 | ||
| PDSUBCAT | Subcategory | Text | Char | $ | 128 | $512 | ||
| PDSUBCATLABEL | Subcategory Label | Text | Char | $ | 128 | $512 | ||
| PDSEV | Severity | Text | Char | $ | 128 | $512 | ||
| PDSEVLABEL | Severity Label | Text | Char | $ | 128 | $512 | ||
| PDDESC | Description | Text | Char | $ | 500 | $2000 | ||
| PDSTATUS | Protocol Deviation Status | Text | Char | $ | 100 | $400 | ||
| PDRES | Protocol Deviation Resolution | Text | Char | $ | 500 | $2000 | ||
| PDRULE | Protocol Deviation Rule | Text | Char | $ | 128 | $512 | ||
| RESTRICTED | Protocol Deviation Restricted | Boolean | Char | 5 | $20 | |||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | 128 | $512 | |||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| USERMODDT | User Modified Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| USERMODB | User Modified By | Text | Char | $ | 201 | $804 | ||
| LASTREAS | Last Change Reason | Text | Char | $ | 255 | $1020 | ||
| INACBYSYS | Inactivated by System | Boolean | Char | $ | 5 | $20 | ||
| LASTINACDT | Last Inactivated Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID of Form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| PDGUID | Internal Vault ID of Protocol Deviation | Text | Char | $ | 15 | $60 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_RAND
The SYS_RAND dataset lists the following Randomization information, if Randomization is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITE | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| RANDSTATUS | Randomization Status | Text | Char | $ | 100 | $400 | ||
| RANDID | Randomization ID | Text | Char | $ | 128 | $512 | ||
| TREATMENTNAME* | Treatment Name | Text | Char | $ | 128 | $512 | ||
| TREATMENTLABEL* | Treatment Label | Text | Char | $ | 1500 | $6000 | ||
| TREATMENTARM* | Treatment Arm | Text | Char | $ | 128 | $512 | Visible if "Include Randomization Treatment" is selected in SDE Version 22R1 or later | |
| RANDSTRATA | Strata Group | Text | Char | $ | 128 | $512 | ||
| RANDBY | Randomized By | Text | Char | $ | 201 | $804 | ||
| RANDDAT | Randomized Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| RANDFILE | Randomization File Label | Text | Char | $ | 128 | $512 | ||
| RANDFILEDAT | Randomization File Upload Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
*These columns are only available for unmasked studies with Randomization enabled and users with the View Unmasked Data and View Randomization Enrollment permissions. To include these columns, check the Include Randomization Treatment box in the New Job dialog. Note that you can’t download SDE files from users with the View Randomization Enrollment permission if the Include Randomization Treatment checkbox is not visible to you in the SDE job dialog.
SYS_LABRANGES
The SYS_LABRANGES dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | |
| LABLOC | Lab Location | Text | Char | $ | 128 | $512 | |
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | |
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 128 | $512 | |
| LABREFRSTATUS | Lab Reference Range Status | Text | Char | $ | 100 | $400 | |
| LABTESTCODE | Test Code | Text | Char | $ | 128 | $512 | |
| LABSEX | Sex | Text | Char | $ | 128 | $512 | |
| LABLOWERAGE | Lower Age | Integer | Num | 14 | 8 | ||
| LABUPPERAGE | Upper Age | Integer | Num | 14 | 8 | ||
| LABAGEUNIT | Age Unit | Text | Char | $ | 128 | $512 | |
| LABFEMCYCLE | Female Cycle | Text | Char | $ | 128 | $512 | |
| LABLNORMAL | Lower Normal | Float | Num | 14 | 8 | ||
| LABUNORMAL | Upper Normal | Float | Num | 14 | 8 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 128 | $512 | |
| LABMEASUNITLABEL | Measurement Unit Label | Text | Char | $ | 128 | $512 | |
| LABCODENORM | Codelist Normal | Text | Char | $ | 128 | $512 | |
| LABTEXTNORM | Text Normal | Text | Char | $ | 3000 | $12000 | |
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | $20 | |
| LABFROMDT | Effective From Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABTODT | Effective To Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABDESCR | Description | Text | Char | $ | 500 | $2000 | |
| LABSPECTYPE | Specimen Type | Text | Char | $ | 128 | $512 | |
| LABTESTMET | Testing Method | Text | Char | $ | 128 | $512 | |
| CREATB | Created By | Text | Char | $ | 201 | $804 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LABLOC
The SYS_LABLOC dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | ||
| LABLOC | Lab Location | Text | Char | $ | 128 | $512 | ||
| LABLOCSTATUS | Lab Location Status | Text | Char | $ | 100 | $400 | ||
| LABAPPROVED | Approved Lab Location | Text | Char | $ | 128 | $512 | ||
| LABADDRESS | Lab Address | Text | Char | $ | 500 | $2000 | ||
| LABCOUNTRY | Lab Country | Text | Char | $ | 128 | $512 | ||
| LABCONTACT | Lab Contact Name | Text | Char | $ | 128 | $512 | ||
| LABCONTITLE | Lab Contact Title | Text | Char | $ | 128 | $512 | ||
| LABTEL | Lab Telephone | Text | Char | $ | 40 | $160 | ||
| LABFAX | Lab Fax | Text | Char | $ | 40 | $160 | ||
| LABPRIMEMAIL | Lab Primary Email | Text | Char | $ | 80 | $320 | ||
| LABSECMAIL | Lab Secondary Email | Text | Char | $ | 80 | $320 | ||
| LABSTATUS | Lab Status | Text | Char | $ | 100 | $400 | ||
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ANALYTES
The SYS_ANALYTES dataset lists the following Labs analyte information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | ||
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 128 | $512 | ||
| LABDESCR | Description | Text | Char | $ | 500 | $2000 | ||
| LABDATATYPE | Data Type | Text | Char | $ | 100 | $400 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 128 | $512 | ||
| LABCODELIST | Codelist | Text | Char | $ | 128 | $512 | ||
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | $20 | ||
| LABSPECTYPE | Specimen Type | Text | Char | $ | 128 | $512 | ||
| LABLEN | Length | Integer | Num | 14 | 8 | |||
| LABPREC | Precision | Integer | Num | 14 | 8 | |||
| LABSYSMANAGED | System Managed | Boolean | Char | $ | 5 | $20 | ||
| LABTESTMET | Testing Method | Text | Char | $ | 128 | $512 | ||
| LABLOINC | LOINC Code | Text | Char | $ | 128 | $512 | ||
| LABSDTMNM | SDTM Name | Text | Char | $ | 255 | $1020 | ||
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
24R1 Version
Clinical Datasets
Each clinical dataset, and each Form (Adverse Events, Concomitant Medications, etc.), contains a set of Key Columns and a set of Clinical Data columns, which are detailed below.
Key Columns
Key Columns contain data to help identify which Form each row is referring to (ex: which Subject, Site, Cycle, or Event that particular form is located in).
The list of Key Columns is as follows:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | 512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| VISMETHOD | Visit Method | Text | Char | $ | 100 | $400 | This column is only visible if Visit Method is enabled. | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| FORMSTATUS | Form Status | Text | Char | 100 | 400 | |||
| CREATEDT | Datetime Form Created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTSUBMITDT | Datetime Form First Submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | This field will only be populated for new studies created after 23R3. |
| LASTSUBMITDT | Datetime Form Last Submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| DLASTMOD | Datetime of last data change (UTC). This field is derived by taking the most recent datetime from all of the items' value_modified_date__v on the form. | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Datetime columns can be separated into two separate Date and Time columns. |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| IGGUID | Internal Vault ID (item groups) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| FORMILB | Intentionally Left Blank | Boolean | Char | $ | 5 | $20 | ||
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (Form Link ItemDef Name)_DEF | [Form Link Item Label] Definition | Text | Char | $ | 200 | $800 | If Item to Form Linking is enabled. Format of the cell value: Form Label that is linked to the item. The Form Sequence (#X) is included if the form is repeating. | |
| (Form Link ItemDef Name)_LINKEDFORMID | [Form Link Item Label] Linked Form ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled. | |
| (Form Link ItemDef Name)_LINKID | [Form Link Item Label] Link ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled. | |
| LINKEDTO 1 | Links to other forms | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| ITEMLINKEDTO 2 | Item Linked To | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| LINKEDITEM | Linked Item | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| (ITEMNAME) | (Item Label) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_UTC | (Item Label)_UTC | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_USER | (Item Label)_User | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
|
1 This column displays in the following format: 2 This column displays in the following format: |
||||||||
This format shows up to 3 items on the form, up to the maximum character limit.
Clinical Data
After the Key Columns, the system will insert Clinical Data columns, with each column representing an item on the Form.
Clinical Data Item Headers use the item names or external ID defined in Studio. Some items can be associated with more than one column, depending on their data type:
- Codelists are split into two columns:
- ITEMNAME: this column contains the codelist code
- ITEMNAME_D: this column contains the codelist decode or label
- Units are split into four columns:
- ITEMNAME: this column contains the value entered in the item
- ITEMNAME_U: this column contains the unit entered in the item
- ITEMNAME_TRANS: this column contains the “translated” item value, which is the value that was entered that has been converted to the standard unit
- ITEMNAME_TRANSU: this column contains the standard unit
- Datetimes are split into three columns:
- ITEMNAME: this column contains the datetime value entered (site’s timezone)
- ITEMNAME_UTC: this column contains the datetime value converted to UTC
- ITEMNAME_USER: this column contains the datetime value converted to the timezone of the user running the Study Data Extract
Unknown parts in dates and datetimes are represented by UN in ISO format:
- For a date: 2021-UN-UN
- For a datetime: 2021-UN-TUN:UN:UN.UNKZ
You can choose from the following Clinical Data options:
| Option | Description |
|---|---|
| Use Item External ID instead of Item Name for column headers | Replaces the column headers in the clinical datasets (which currently use the Item Name) with the Item External ID configured in Studio |
| Include Separate Date and Time columns for Datetime items | Creates two additional columns with the postfixes (Item)_DT and (Item)_TM for the Date and Time of the Datetime item |
| Include forms Intentionally Left Blank | Creates a column in the clinical datasets called FORMILB that indicates whether the form has been marked Intentionally Left Blank in clinical datasets (default behavior is to skip rows) |
| Exclude blank forms | Excludes forms whose status = "Blank" in the clinical datasets. Note that these forms will still appear in the SYS_FORM dataset |
Casebook Versions
All casebook versions are displayed in Study Data Extracts, so items that were deleted from the schedule in subsequent casebook versions will still appear in Clinical Datasets. This inclusion guarantees that all data is extracted, even if certain subjects were kept on a previous casebook version.
The Study Data Extract job first adds columns for all items that are present in Casebook Version 1 before adding columns for any items that may have been added in subsequent casebook versions to create the Study Data Extract file.
Lab Columns
Each form configured with Local Labs contains certain columns that are dynamically added after the LASTRUN column for lab items. Refer to the table below for a complete list of columns.
23R1 Version Lab Format Change: Clinical forms that are configured with Local Labs are formatted to decrease the number of columns outputted in SDE Version 23R1. In this version, Labs columns are shared across all analytes on the form instead of using multiple columns per analyte. See the SDE Versioning page for the list of Labs columns included in previous SDE versions.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | 128 | $512 | |||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | :vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| DLASTMOD | Datetime of last data change (UTC) | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| IGGUID | Internal Vault ID (Item Groups) | Text | Char | $ | 15 | $60 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| LBDTC | Collection Date Time | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBDTC_UTC | Collection Date Time_UTC | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBDTC_USER | Collection Date Time_USER | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBLOC | Lab Location* | Text | Char | $ | 128 | $512 | ||
| LBAGE | Age | Integer | Num | 14 | 8 | |||
| LBAGE_U | Age_U | Text | Char | 128 | $512 | |||
| LBAGE_TRANS | Age_TRANS | Integer | Num | 14 | 8 | |||
| LBAGE_TRANSU | Age_TRANSU | Text | Char | $ | 128 | $512 | ||
| LBTEST | Lab Test | Text | Char | $ | 128 | $512 | ||
| LABMODIFIER | Lab Modifier | Text | Char | $ | 128 | $512 | Visible for Studies using Global (Versionless) Labs if at least one analyte definition has Lab Modifiers configured. | |
| LABMODIFIER_D | Lab Modifier_D | Text | Char | $ | 256 | $1024 | Visible for Studies using Global (Versionless) Labs if at least one analyte definition has Lab Modifiers configured. | |
| LBORRES | Lab Result | Text, Float, or Integer | Char or Num | $ | 1500 or 14 | $6000 or 8 | Data type may be float or integer if all cells in that column have the same data type. Note that if the data type is float or integer, the length/SAS length may change to the default for numeric values. | |
| LBORRES_U_D | Lab Result Unit or Decode for Codelists and Units | Text | Char | $ | 1500 | $6000 | Visible for Unit, Number, Codelist, or Text analyte type. | |
| LBORRES_TRANS | Lab Result_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORRES_TRANSU | Lab Result_TRANSU | Text | Char | $ | 1500 | $6000 | ||
| LBORNRLO | Normal Range Lower Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRHI | Normal Range Upper Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRLOHI_U | Normal Range Lower and Upper Limit_U | Text | Char | $ | 1500 | $6000 | ||
| LBORNRLO_TRANS | Normal Range Lower Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRHI_TRANS | Normal Range Upper Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRLOHI_TRANSU | Normal Range Lower and Upper Limit_TRANSU | Text | Char | $ | 1500 | $6000 | ||
| LBOVRDNRLO | Normal Range Override Lower Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDNRHI | Normal Range Override Upper Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDNRLOHI_U | Normal Range Override Lower and Upper Limit_U | Text | Char | $ | 1500 | $6000 | ||
| LBOVRDNRLO_TRANS | Normal Range Override Lower Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDRLOHI_TRANSU | Normal Range Override Lower and Upper Limit_TRANSU | Text | Char | $ | 1500 | $6000 | Data type may be integer if all cells in that column are integers. | |
| LBSTNRC | Normal Value | Text | Char | $ | 1500 | $6000 | For Codelist or Text-type Analytes. | |
| LBSTNRC_D | Normal Value_D | Text | Char | $ | 256 | $1024 | For Codelist-type Analytes. | |
| LBOVRDNRC | Normal Value Override | Text | Char | $ | 1500 | $6000 | For Codelist or Text-type Analytes. | |
| LBOVRDNRC_D | Normal Value Override_D | Text | Char | $ | 256 | $1024 | For Codelist-type Analytes. | |
| LBNRIND | Normal Range Indicator | Text | Char | $ | 1500 | $6000 | ||
| LBCLSIG | Clinical Significance | Text | Char | $ | 1500 | $6000 |
*This field refers to the Lab ID.
The LBDTC, LBLOC, and LBAGE columns are part of the Lab Header that is generated for each lab form. Each column related to a Lab Analyte with a “Unit” type has additional columns for the Unit (appended with _U), the Translated Value (appended with _TRANS), and the Translated Unit (appended with _TRANSU). For example, the Lab Result Unit for Sodium would display in the column header as LBORRES_Sodium_U.
Coding Data
If a form is set up for coding, meaning that a coding configuration has been defined in Studio, coding-related columns will be added after clinical data columns. If there are multiple verbatims set up in a form, the system will add a set of coding columns for each verbatim configured. If the same item in different item groups is configured for coding, the system will add “itemgroup.item” to each column header to indicate which set of columns belongs to which verbatim. Note that you need the View Code permission to view coding columns in the SDE.
List of coding columns for MedDRA:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| SOC | SOC | Text | Char | $ | 1500 | $6000 | |
| SOCID | SOC Code | Text | Char | $ | 1500 | $6000 | |
| HLGT | HLGT | Text | Char | $ | 1500 | $6000 | |
| HLGTID | HLGT Code | Text | Char | $ | 1500 | $6000 | |
| HLT | HLT | Text | Char | $ | 1500 | $6000 | |
| HLTID | HLT Code | Text | Char | $ | 1500 | $6000 | |
| PT | PT | Text | Char | $ | 1500 | $6000 | |
| PTID | PT Code | Text | Char | $ | 1500 | $6000 | |
| LLT | LLT | Text | Char | $ | 1500 | $6000 | |
| LLTID | LLT Code | Text | Char | $ | 1500 | $6000 | |
| PRIMPATH | Primary Path | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
List of coding columns for WHODrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| ATC1 | ATC1 | Text | Char | $ | 1500 | $6000 | |
| ATC1CD | ATC1 Code | Text | Char | $ | 1500 | $6000 | |
| ATC2 | ATC2 | Text | Char | $ | 1500 | $6000 | |
| ATC2CD | ATC2 Code | Text | Char | $ | 1500 | $6000 | |
| ATC3 | ATC3 | Text | Char | $ | 1500 | $6000 | |
| ATC3CD | ATC3 Code | Text | Char | $ | 1500 | $6000 | |
| ATC4 | ATC4 | Text | Char | $ | 1500 | $6000 | |
| ATC4CD | ATC4 Code | Text | Char | $ | 1500 | $6000 | |
| PREFNAME | Preferred Name | Text | Char | $ | 1500 | $6000 | |
| PREFCODE | Preferred Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| PREFBASE | Preferred Base Code | Text | Char | $ | 1500 | $6000 | |
| PREFLABEL | Preferred Base | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
List of coding columns for JDrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| GDRUGNAME | Generic Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT1 | Drug Code Category 1 | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT2 | Drug Code Category 2 | Text | Char | $ | 1500 | $6000 | |
| USECAT1 | Use Category 1 | Text | Char | $ | 1500 | $6000 | |
| USECAT2 | Use Category 2 | Text | Char | $ | 1500 | $6000 | |
| MANNAME | Manufacturer Name | Text | Char | $ | 1500 | $6000 | |
| MANCODE | Manufacturer Code | Text | Char | $ | 1500 | $6000 | |
| MAINTFLG | Maintenance Flag | Text | Char | $ | 1500 | $6000 | |
| MAINTDT | Maintenance Date | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
Definitions File
The Study Data Extract ZIP file contains a definition file, which is a listing of all columns across all datasets included in the extract.
List of columns included in the Definitions file:
| Column Header | Data |
|---|---|
| Dataset Name | Name of the dataset |
| Column | Name of the column |
| Type | Item type for clinical data items |
| SAS Type | SAS type of the column |
| SAS Informat | SAS informat applied |
| SAS Format | SAS format applied |
| Length | Length in characters |
| SAS Length | SAS length in bytes |
| Label | SAS Label of the column |
System Datasets
Along with clinical datasets, the Study Data Extract file contains several system datasets that contain operational data and metrics.
SYS_SITE
The SYS_SITE dataset lists all sites for the selected study.
List of SYS_SITE columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Study Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SITENAME | Study Site Name | Text | Char | $ | 128 | $512 | ||
| INVNAME | Principal Investigator | Text | Char | $ | 128 | $512 | ||
| CASEBDEF | Casebook Version | Integer | Num | 14 | 8 | |||
| STATUS | Site Status | Text | Char | $ | 100 | $400 | ||
| TIMEZONE | Timezone of the Site | Text | Char | $ | 100 | $400 | ||
| BULKCASEBOOKSIGNATURE | Bulk Casebook Signature | Boolean | Char | $ | 5 | $20.00 | ||
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_SUB
The SYS_SUB dataset lists all subjects for the selected study.
List of SYS_SUB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| IXRSID | Subject IXRS ID | Text | Char | $ | 255 | $1020 | This column refers to an external Subject ID that may be set through API or Integration. | |
| CASEBDEF | Casebook Version | Integer | Num | 14 | 8 | |||
| STATUS | Status of the Subject/Casebook | Text | Char | $ | 100 | $400 | ||
| SDVPLAN | SDV Plan | Text | Char | $ | 128 | $512 | ||
| DMRPLAN | DMR Plan | Text | Char | $ | 128 | $512 | ||
| FROZEN | Subject Frozen | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| LOCKED | Subject Locked | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| SIGNED | Subject Signed | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| GUID | Internal Vault ID of the subject | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTMODDT | Subject Last Modified Datetime | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LATESTARM | Latest Arm | Text | Char | $ | 128 | $512 | ||
| LATESTCOHORT | Latest Cohort | Text | Char | $ | 128 | $512 | ||
| LATEST SUBSTUDY | Latest Substudy | Text | Char | $ | 128 | $512 | ||
| CNSNTDT | Initial Consent Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| SCRDDT | Screened date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| SCRFAILDT | Screen failed date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ENRDDT | Enrolled date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| RDMDDT | Randomized date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| STARTTRTDT | Started Treatment Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ENDTRTDT | End of treatment date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| WTHDRWNDT | Withdrawn date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| STARTFLLWUPDT | Started Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| LOSTFLLWUPDT | Lost to Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| CMPLTDT | End of study date | Date | Num | : vdate. | DATE9. | 14 | 8 |
SYS_EVT
The SYS_EVT dataset lists all events as well as event dates and status for the selected study.
List of SYS_EVT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9 | 14 | 8 | |
| VISMETHOD | Visit Method | Text | Char | $ | 100 | $400 | This column is only visible if Visit Method is enabled. | |
| PLANNEDDT | Planned Date | Date | Num | : vdate. | DATE9 | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| LASTMODDAT | Last modified date/time of the event date (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CASEBDEF | Casebook Version | Integer | Num | $ | 14 | 8 | ||
| STATUS | Status of the event/visit | Text | Char | $ | 100 | $400 | ||
| LASTREAS | Last change reason | Text | Char | $ | 255 | $1020 | ||
| WINSTAT | Scheduled Window Status | Text | Char | $ | 32 | $128 | ||
| DAYSOW | Days Outside Window | Integer | Num | 14 | 8 | |||
| EXPFORMS | Expected Number of Forms | Integer | Num | 14 | 8 | |||
| FORMEOD | Number of days past due when one or more forms is not yet complete | Integer | Num | 14 | 8 | |||
| EVFROZEN | Event Frozen | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| EVFREEZEDT | Event Frozen Datetime | Date | Num | : vdate. | DATETIME22.3 | 14 | 8 | Populated for Data Model 2 studies only. |
| EVLOCKED | Event Locked | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| EVLOCKDT | Event Locked Datetime | Date | Num | : vdate. | DATETIME22.3 | 14 | 8 | Populated for Data Model 2 studies only. |
| EVSIGNED | Event Signed | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| EVSIGNDT | Event Signed Datetime | Date | Num | : vdate. | DATETIME22.3 | 14 | 8 | Populated for Data Model 2 studies only. |
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_FORM
The SYS_FORM dataset lists all forms for the selected study, including forms Intentionally Left Blank as well as review statuses, freeze and lock statuses, and additional metrics.
List of SYS_FORM columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| STATUS | Form Status | Text | Char | $ | 100 | $400 | ||
| CREATEDT | Datetime form created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTSUBMITDT | Datetime form first submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | This field will only be populated for new studies created after 23R3. |
| LASTSUBMITDT | Datetime form last submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Number of times form was submitted | Integer | Num | 14 | 8 | |||
| SDVOVRPLAN | SDV Override Plan | Text | Char | $ | 128 | $512 | Populated for Data Model 2 studies only. | |
| SDVREQ | SDV Required | Boolean | Char | $ | 5 | $20 | Not supported for SDV rollup V1 studies, will be blank | |
| SDVCOMP | SDV Complete | Boolean | Char | $ | 5 | $20 | Populated for SDV Rollup v2 studies only. | |
| SDVDT | Datetime considered SDV complete (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTSDVDT | Datetime Form First SDV Complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| SDVLAST | Datetime of last SDV modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TOSDV | Days from submit to SDV | Float | Num | 14 | 8 | |||
| DMROVRPLAN | DMR Override Plan | Text | Char | $ | 128 | $512 | Populated for Data Model 2 studies only. | |
| DMRREQ | DMR Required | Boolean | Char | $ | 5 | $20 | Not supported for SDV rollup V1 studies, will be blank | |
| DMRCOMP | DMR Complete | Boolean | Char | $ | 5 | $20 | Populated for SDV Rollup v2 studies only. | |
| DMRDT | Datetime considered DMR complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTDMRDT | Datetime Form First DMR Complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| DMRLAST | Datetime of last DMR modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TODMR | Days from submit to DMR | Float | Num | 14 | 8 | |||
| FROZEN | Form Frozen | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| FREEZEDT | Datetime frozen (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOFREEZE | Days from submit to freeze | Float | Num | 14 | 8 | |||
| LOCKED | Form Locked | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| LOCKDT | Datetime locked (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOLOCK | Days from submit to lock | Float | Num | 14 | 8 | |||
| SIGNED | Form Signed | Boolean | Char | $ | 5 | $20 | Populated for Data Model 2 studies only. | |
| SIGNDT | Datetime signed (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LSTSGNDT | Last Signature Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOSIGN | Days from submit to sign | Float | Num | 14 | 8 | |||
| EDT_SUBM | Days from event date (of form) to submit date | Float | Num | 14 | 8 | |||
| ILB | Intentionally Left Blank | Boolean | Char | $ | 5 | $20 | ||
| ILBREAS | Reason for Intentionally Left Blank | Text | Char | $ | 255 | $1020 | ||
| GUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_Q
The SYS_Q dataset lists all queries for the selected study, along with some query metrics. Only the first query message is listed in this dataset. The full list of query messages (first message, answers, etc.) is included in the SYS_QT dataset.
List of SYS_Q columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | 512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGROUPDEF | Item Group Definition Name | Text | Char | $ | 128 | 512 | ||
| IGSEQ | Item group sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | 128 | $512 | |||
| QUERYID | Query ID | Text | Char | $ | 128 | $512 | ||
| STATUS | Query status | Text | Char | $ | 100 | $400 | Includes Open, Answered, and Closed queries. | |
| RESTRICTED | Query Restricted | Boolean | Char | 5 | $20 | Visible if "Include Restricted Data" is selected in SDE Version 23R1. | ||
| MANUAL | Manual query | Boolean | Char | $ | 5 | $20 | ||
| RULEID | Rule name | Text | Char | $ | 128 | $512 | ||
| TRIGID | Trigger name | Text | Char | $ | 128 | $512 | ||
| QTEXT | Initial query text/message | Text | Char | $ | 500 | $2000 | ||
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created by | Text | Char | $ | 201 | $804 | ||
| LASTCLOSEDDT | Query Last Closed Date | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| QUERYTEAM | Query team | Text | Char | $ | 50 | $200 | ||
| QTFRESP | Time to first response (days) | Float | Num | 14 | 8 | Only populated when there's a First Response Date and the query has a status of "Answered." | ||
| QAGE | Query Age (days) | Float | Num | 14 | 8 | |||
| QCHGDATA | Whether the data changed after query creation (field query attached) | Boolean | Char | $ | 5 | $20 | ||
| QOTOCL | Query open to close (days) | Float | Num | 14 | 8 | |||
| GUID | Internal Vault ID of the query | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_QT
The SYS_QT dataset lists all query messages for the selected study.
You can link the content of this file with the SYS_Q dataset using the QUERYID column. There can be multiple SYS_QT records matching one SYS_Q record (i.e. a query in SYS_Q can have multiple query messages in SYS_QT).
List of SYS_QT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| QUERYID | Query ID | Text | Char | $ | 128 | $512 | ||
| STATUS | Query status | Text | Char | $ | 100 | $400 | Includes Open, Answered, Closed, and Reopened queries | |
| RESTRICTED | Query Restricted | Boolean | Char | 5 | $20 | Visible if "Include Restricted Data" is selected in SDE Version 23R1. | ||
| QTEXT | Initial query text/message | Text | Char | $ | 500 | $2000 | ||
| TEXTDT | Text/Message Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TEXTBY | Text/Message By | Text | Char | $ | 201 | $1804 | ||
| QUERYTEAM | Query team | Text | Char | $ | 50 | $200 | ||
| GUID | Internal Vault ID of the query message | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ILB
The SYS_ILB dataset lists all items that have been marked Intentionally Left Blank in the selected study.
List of SYS_ILB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition Name | Text | Char | 128 | 512 | |||
| IGROUPEID | Item Group External ID | Text | Char | 128 | 512 | |||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | $ | 128 | $512 | ||
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | Visible if Local Labs is enabled | |
| ILBREAS | Reason for intentionally left blank | Text | Char | $ | 255 | $1020 | ||
| GUID | Internal Vault ID of the item/field | Text | Char | $ | 100 | $400 | For HVO objects (item2__v), the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LINKS
The SYS_LINKS dataset lists all forms that belong to a form link in the selected study. Forms that are linked together will share the same link ID, which will display in the GUID column. The form unique identifier (FGUID) can then be used to identify a specific form and access its data.
List of SYS_LINKS columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Description |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form external ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | Only visible if Form Linking is enabled. | |
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | Only visible if Form Linking is enabled. | |
| ITEMEID | Item External ID | Text | Char | 128 | $512 | Only visible if Form Linking is enabled. | ||
| FORMCREATEDDT | Form Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LINKCREATEDDT | Link Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created by | Text | Char | $ | 201 | $804 | ||
| FGUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| GUID | Internal Link ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASM
The SYS_ASM dataset lists the following information about assessments, if assessments are configured for a Study.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| SOURCEF | Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| SOURCEFEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| ASMNAME | Assessment Name | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| ASMEID | Assessment External ID | Text | Char | $ | 128 | $512 | ||
| ASMTYPE | Assessment Type | Text | Char | $ | 128 | $512 | ||
| REASSESSMENT | Reassessment | Boolean | Char | $ | 5 | $20 | ||
| SOURCEF | Source Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| STATUS | Status of Assessment | Text | Char | $ | 100 | $400 | ||
| SOURCEFRESTRICTED | Source Form Restricted | Boolean | Char | $ | 5 | $20 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| COMPDT | Completed Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Submit Count | Integer | Num | 14 | 8 | |||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| GUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| FGUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASMR
The SYS_ASMR dataset lists questions and answers for all assessments in a Study, if assessments are configured.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| SOURCEF | Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| SOURCEFEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| QUESNUM | Question Number | Integer | Num | 14 | 8 | |||
| ASMNAME | Assessment Name | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| ASMEID | Assessment External ID | Text | Char | $ | 128 | $512 | ||
| QUESTEXT | Question Text | Text | Char | $ | 128 | $512 | ||
| QUESTEXTDEF | Question Text Definition | Text | Char | $ | 128 | $512 | ||
| QUESEID | Question External ID | Text | Char | $ | 128 | $512 | ||
| QUESANS | Question Answer | Text | Char | $ | 1500 | $6000 | ||
| SOURCEFRESTRICTED | Source Form Restricted | Boolean | Char | $ | 5 | $20 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| AGUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_PD
The SYS_PD dataset lists the following Protocol Deviations information, if Protocol Deviations is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| PDID | Protocol Deviation Identifier | Text | Char | $ | 128 | $512 | ||
| PDSUM | Protocol Deviation Summary | Text | Char | $ | 250 | $1000 | ||
| PDDAT | Date of Deviation | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDDATID | Date Identified | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDCAT | Category | Text | Char | $ | 128 | $512 | ||
| PDCATLABEL | Category Label | Text | Char | $ | 128 | $512 | ||
| PDSUBCAT | Subcategory | Text | Char | $ | 128 | $512 | ||
| PDSUBCATLABEL | Subcategory Label | Text | Char | $ | 128 | $512 | ||
| PDSEV | Severity | Text | Char | $ | 128 | $512 | ||
| PDSEVLABEL | Severity Label | Text | Char | $ | 128 | $512 | ||
| PDDESC | Description | Text | Char | $ | 500 | $2000 | ||
| PDSTATUS | Protocol Deviation Status | Text | Char | $ | 100 | $400 | ||
| PDRES | Protocol Deviation Resolution | Text | Char | $ | 500 | $2000 | ||
| PDRULE | Protocol Deviation Rule | Text | Char | $ | 128 | $512 | ||
| RESTRICTED | Protocol Deviation Restricted | Boolean | Char | 5 | $20 | |||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | 128 | $512 | |||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| USERMODDT | User Modified Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| USERMODB | User Modified By | Text | Char | $ | 201 | $804 | ||
| INACBYSYS | Inactivated by System | Boolean | Char | $ | 5 | $20 | ||
| LASTINACDT | Last Inactivated Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID of Form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| PDGUID | Internal Vault ID of Protocol Deviation | Text | Char | $ | 15 | $60 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_RAND
The SYS_RAND dataset lists the following Randomization information, if Randomization is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITE | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| RANDSTATUS | Randomization Status | Text | Char | $ | 100 | $400 | ||
| RANDID | Randomization ID | Text | Char | $ | 128 | $512 | ||
| TREATMENTNAME* | Treatment Name | Text | Char | $ | 128 | $512 | ||
| TREATMENTLABEL* | Treatment Label | Text | Char | $ | 1500 | $6000 | ||
| TREATMENTARM* | Treatment Arm | Text | Char | $ | 128 | $512 | Visible if "Include Randomization Treatment" is selected in SDE Version 22R1 or later | |
| RANDSTRATA | Strata Group | Text | Char | $ | 128 | $512 | ||
| RANDBY | Randomized By | Text | Char | $ | 201 | $804 | ||
| RANDDAT | Randomized Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| RANDFILE | Randomization File Label | Text | Char | $ | 128 | $512 | ||
| RANDFILEDAT | Randomization File Upload Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
*These columns are only available for unmasked studies with Randomization enabled and users with the View Unmasked Data and View Randomization Enrollment permissions. To include these columns, check the Include Randomization Treatment box in the New Job dialog. Note that you can’t download SDE files from users with the View Randomization Enrollment permission if the Include Randomization Treatment checkbox is not visible to you in the SDE job dialog.
SYS_LABRANGES
The SYS_LABRANGES dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | |
| LABLOC | Lab Location | Text | Char | $ | 128 | $512 | |
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | |
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 128 | $512 | |
| LABREFRSTATUS | Lab Reference Range Status | Text | Char | $ | 100 | $400 | |
| LABTESTCODE | Test Code | Text | Char | $ | 128 | $512 | |
| LABSEX | Sex | Text | Char | $ | 128 | $512 | |
| LABLOWERAGE | Lower Age | Integer | Num | 14 | 8 | ||
| LABUPPERAGE | Upper Age | Integer | Num | 14 | 8 | ||
| LABAGEUNIT | Age Unit | Text | Char | $ | 128 | $512 | |
| LABFEMCYCLE | Female Cycle | Text | Char | $ | 128 | $512 | |
| LABLNORMAL | Lower Normal | Float | Num | 14 | 8 | ||
| LABUNORMAL | Upper Normal | Float | Num | 14 | 8 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 128 | $512 | |
| LABMEASUNITLABEL | Measurement Unit Label | Text | Char | $ | 128 | $512 | |
| LABCODENORM | Codelist Normal | Text | Char | $ | 128 | $512 | |
| LABTEXTNORM | Text Normal | Text | Char | $ | 3000 | $12000 | |
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | $20 | |
| LABFROMDT | Effective From Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABTODT | Effective To Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABDESCR | Description | Text | Char | $ | 500 | $2000 | |
| LABSPECTYPE | Specimen Type | Text | Char | $ | 128 | $512 | |
| LABTESTMET | Testing Method | Text | Char | $ | 128 | $512 | |
| CREATB | Created By | Text | Char | $ | 201 | $804 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LABLOC
The SYS_LABLOC dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | ||
| LABLOC | Lab Location | Text | Char | $ | 128 | $512 | ||
| LABLOCSTATUS | Lab Location Status | Text | Char | $ | 100 | $400 | ||
| LABAPPROVED | Approved Lab Location | Text | Char | $ | 128 | $512 | ||
| LABADDRESS | Lab Address | Text | Char | $ | 500 | $2000 | ||
| LABCOUNTRY | Lab Country | Text | Char | $ | 128 | $512 | ||
| LABCONTACT | Lab Contact Name | Text | Char | $ | 128 | $512 | ||
| LABCONTITLE | Lab Contact Title | Text | Char | $ | 128 | $512 | ||
| LABTEL | Lab Telephone | Text | Char | $ | 40 | $160 | ||
| LABFAX | Lab Fax | Text | Char | $ | 40 | $160 | ||
| LABPRIMEMAIL | Lab Primary Email | Text | Char | $ | 80 | $320 | ||
| LABSECMAIL | Lab Secondary Email | Text | Char | $ | 80 | $320 | ||
| LABSTATUS | Lab Status | Text | Char | $ | 100 | $400 | ||
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ANALYTES
The SYS_ANALYTES dataset lists the following Labs analyte information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | ||
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 128 | $512 | ||
| LABDESCR | Description | Text | Char | $ | 500 | $2000 | ||
| LABDATATYPE | Data Type | Text | Char | $ | 100 | $400 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 128 | $512 | ||
| LABCODELIST | Codelist | Text | Char | $ | 128 | $512 | ||
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | $20 | ||
| LABSPECTYPE | Specimen Type | Text | Char | $ | 128 | $512 | ||
| LABLEN | Length | Integer | Num | 14 | 8 | |||
| LABPREC | Precision | Integer | Num | 14 | 8 | |||
| LABSYSMANAGED | System Managed | Boolean | Char | $ | 5 | $20 | ||
| LABTESTMET | Testing Method | Text | Char | $ | 128 | $512 | ||
| LABLOINC | LOINC Code | Text | Char | $ | 128 | $512 | ||
| LABSDTMNM | SDTM Name | Text | Char | $ | 255 | $1020 | ||
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
23R3 Version
Clinical Datasets
Each clinical dataset, and each Form (Adverse Events, Concomitant Medications, etc.), contains a set of Key Columns and a set of Clinical Data columns, which are detailed below.
Key Columns
Key Columns contain data to help identify which Form each row is referring to (ex: which Subject, Site, Cycle, or Event that particular form is located in).
The list of Key Columns is as follows:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | 512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| FORMSTATUS | Form Status | Text | Char | 100 | 400 | |||
| CREATEDT | Datetime Form Created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTSUBMITDT | Datetime Form First Submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | This field will only be populated for new studies created after 23R3. |
| LASTSUBMITDT | Datetime Form Last Submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| DLASTMOD | Datetime of last data change (UTC). This field is derived by taking the most recent datetime from all of the items' value_modified_date__v on the form. | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Datetime columns can be separated into two separate Date and Time columns. |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| IGGUID | Internal Vault ID (item groups) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| FORMILB | Intentionally Left Blank | Boolean | Char | $ | 5 | $20 | ||
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (Form Link ItemDef Name)_DEF | [Form Link Item Label] Definition | Text | Char | $ | 200 | $800 | If Item to Form Linking is enabled. Format of the cell value: Form Label that is linked to the item. The Form Sequence (#X) is included if the form is repeating. | |
| (Form Link ItemDef Name)_LINKEDFORMID | [Form Link Item Label] Linked Form ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled. | |
| (Form Link ItemDef Name)_LINKID | [Form Link Item Label] Link ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled. | |
| LINKEDTO* | Links to other forms | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| ITEMLINKEDTO | Item Linked To | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| LINKEDITEM | Linked Item | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| (ITEMNAME) | (Item Label) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_UTC | (Item Label)_UTC | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_USER | (Item Label)_User | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
*This column displays in the following format:
X Form(s): <Form Definition Label> [Form Definition Name] (#Y) – <Item Name 1> = <Item Value 1>, <Item Name 2> = <Item Value 2>, <Item Name 3> = <Item Value 3>
- X = total number of linked forms
- Y = number that is incremented
This format shows up to 3 items on the form, up to the maximum character limit.
Clinical Data
After the Key Columns, the system will insert Clinical Data columns, with each column representing an item on the Form.
Clinical Data Item Headers use the item names or external ID defined in Studio. Some items can be associated with more than one column, depending on their data type:
- Codelists are split into two columns:
- ITEMNAME: this column contains the codelist code
- ITEMNAME_D: this column contains the codelist decode or label
- Units are split into four columns:
- ITEMNAME: this column contains the value entered in the item
- ITEMNAME_U: this column contains the unit entered in the item
- ITEMNAME_TRANS: this column contains the “translated” item value, which is the value that was entered that has been converted to the standard unit
- ITEMNAME_TRANSU: this column contains the standard unit
- Datetimes are split into three columns:
- ITEMNAME: this column contains the datetime value entered (site’s timezone)
- ITEMNAME_UTC: this column contains the datetime value converted to UTC
- ITEMNAME_USER: this column contains the datetime value converted to the timezone of the user running the Study Data Extract
Unknown parts in dates and datetimes are represented by UN in ISO format:
- For a date: 2021-UN-UN
- For a datetime: 2021-UN-TUN:UN:UN.UNKZ
You can choose from the following Clinical Data options:
| Option | Description |
|---|---|
| Use Item External ID instead of Item Name for column headers | Replaces the column headers in the clinical datasets (which currently use the Item Name) with the Item External ID configured in Studio |
| Include Separate Date and Time columns for Datetime items | Creates two additional columns with the postfixes (Item)_DT and (Item)_TM for the Date and Time of the Datetime item |
| Include forms Intentionally Left Blank | Creates a column in the clinical datasets called FORMILB that indicates whether the form has been marked Intentionally Left Blank in clinical datasets (default behavior is to skip rows) |
| Exclude blank forms | Excludes forms whose status = "Blank" in the clinical datasets. Note that these forms will still appear in the SYS_FORM dataset |
Casebook Versions
All casebook versions are displayed in Study Data Extracts, so items that were deleted from the schedule in subsequent casebook versions will still appear in Clinical Datasets. This inclusion guarantees that all data is extracted, even if certain subjects were kept on a previous casebook version.
The Study Data Extract job first adds columns for all items that are present in Casebook Version 1 before adding columns for any items that may have been added in subsequent casebook versions to create the Study Data Extract file.
Lab Columns
Each form configured with Local Labs contains certain columns that are dynamically added after the LASTRUN column for lab items. Refer to the table below for a complete list of columns.
23R1 Version Lab Format Change: Clinical forms that are configured with Local Labs are formatted to decrease the number of columns outputted in SDE Version 23R1. In this version, Labs columns are shared across all analytes on the form instead of using multiple columns per analyte. See the SDE Versioning page for the list of Labs columns included in previous SDE versions.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | 128 | $512 | |||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | :vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| DLASTMOD | Datetime of last data change (UTC) | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| IGGUID | Internal Vault ID (Item Groups) | Text | Char | $ | 15 | $60 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| LBDTC | Collection Date Time | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBDTC_UTC | Collection Date Time_UTC | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBDTC_USER | Collection Date Time_USER | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBLOC | Lab Location* | Text | Char | $ | 128 | $512 | ||
| LBAGE | Age | Integer | Num | 14 | 8 | |||
| LBAGE_U | Age_U | Text | Char | 128 | $512 | |||
| LBAGE_TRANS | Age_TRANS | Integer | Num | 14 | 8 | |||
| LBAGE_TRANSU | Age_TRANSU | Text | Char | $ | 128 | $512 | ||
| LBTEST | Lab Test | Text | Char | $ | 128 | $512 | ||
| LABMODIFIER | Lab Modifier | Text | Char | $ | 128 | $512 | Visible for Studies using Global (Versionless) Labs if at least one analyte definition has Lab Modifiers configured. | |
| LABMODIFIER_D | Lab Modifier_D | Text | Char | $ | 256 | $1024 | Visible for Studies using Global (Versionless) Labs if at least one analyte definition has Lab Modifiers configured. | |
| LBORRES | Lab Result | Text, Float, or Integer | Char or Num | $ | 1500 or 14 | $6000 or 8 | Data type may be float or integer if all cells in that column have the same data type. Note that if the data type is float or integer, the length/SAS length may change to the default for numeric values. | |
| LBORRES_U_D | Lab Result Unit or Decode for Codelists and Units | Text | Char | $ | 1500 | $6000 | Visible for Unit, Number, Codelist, or Text analyte type. | |
| LBORRES_TRANS | Lab Result_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORRES_TRANSU | Lab Result_TRANSU | Text | Char | $ | 1500 | $6000 | ||
| LBORNRLO | Normal Range Lower Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRHI | Normal Range Upper Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRLOHI_U | Normal Range Lower and Upper Limit_U | Text | Char | $ | 1500 | $6000 | ||
| LBORNRLO_TRANS | Normal Range Lower Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRHI_TRANS | Normal Range Upper Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRLOHI_TRANSU | Normal Range Lower and Upper Limit_TRANSU | Text | Char | $ | 1500 | $6000 | ||
| LBOVRDNRLO | Normal Range Override Lower Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDNRHI | Normal Range Override Upper Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDNRLOHI_U | Normal Range Override Lower and Upper Limit_U | Text | Char | $ | 1500 | $6000 | ||
| LBOVRDNRLO_TRANS | Normal Range Override Lower Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDRLOHI_TRANSU | Normal Range Override Lower and Upper Limit_TRANSU | Text | Char | $ | 1500 | $6000 | Data type may be integer if all cells in that column are integers. | |
| LBSTNRC | Normal Value | Text | Char | $ | 1500 | $6000 | For Codelist or Text-type Analytes. | |
| LBSTNRC_D | Normal Value_D | Text | Char | $ | 256 | $1024 | For Codelist-type Analytes. | |
| LBOVRDNRC | Normal Value Override | Text | Char | $ | 1500 | $6000 | For Codelist or Text-type Analytes. | |
| LBOVRDNRC_D | Normal Value Override_D | Text | Char | $ | 256 | $1024 | For Codelist-type Analytes. | |
| LBNRIND | Normal Range Indicator | Text | Char | $ | 1500 | $6000 | ||
| LBCLSIG | Clinical Significance | Text | Char | $ | 1500 | $6000 |
*This field refers to the Lab ID.
The LBDTC, LBLOC, and LBAGE columns are part of the Lab Header that is generated for each lab form. Each column related to a Lab Analyte with a “Unit” type has additional columns for the Unit (appended with _U), the Translated Value (appended with _TRANS), and the Translated Unit (appended with _TRANSU). For example, the Lab Result Unit for Sodium would display in the column header as LBORRES_Sodium_U.
Coding Data
If a form is set up for coding, meaning that a coding configuration has been defined in Studio, coding-related columns will be added after clinical data columns. If there are multiple verbatims set up in a form, the system will add a set of coding columns for each verbatim configured. If the same item in different item groups is configured for coding, the system will add “itemgroup.item” to each column header to indicate which set of columns belongs to which verbatim. Note that you need the View Code permission to view coding columns in the SDE.
List of coding columns for MedDRA:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| SOC | SOC | Text | Char | $ | 1500 | $6000 | |
| SOCID | SOC Code | Text | Char | $ | 1500 | $6000 | |
| HLGT | HLGT | Text | Char | $ | 1500 | $6000 | |
| HLGTID | HLGT Code | Text | Char | $ | 1500 | $6000 | |
| HLT | HLT | Text | Char | $ | 1500 | $6000 | |
| HLTID | HLT Code | Text | Char | $ | 1500 | $6000 | |
| PT | PT | Text | Char | $ | 1500 | $6000 | |
| PTID | PT Code | Text | Char | $ | 1500 | $6000 | |
| LLT | LLT | Text | Char | $ | 1500 | $6000 | |
| LLTID | LLT Code | Text | Char | $ | 1500 | $6000 | |
| PRIMPATH | Primary Path | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
List of coding columns for WHODrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| ATC1 | ATC1 | Text | Char | $ | 1500 | $6000 | |
| ATC1CD | ATC1 Code | Text | Char | $ | 1500 | $6000 | |
| ATC2 | ATC2 | Text | Char | $ | 1500 | $6000 | |
| ATC2CD | ATC2 Code | Text | Char | $ | 1500 | $6000 | |
| ATC3 | ATC3 | Text | Char | $ | 1500 | $6000 | |
| ATC3CD | ATC3 Code | Text | Char | $ | 1500 | $6000 | |
| ATC4 | ATC4 | Text | Char | $ | 1500 | $6000 | |
| ATC4CD | ATC4 Code | Text | Char | $ | 1500 | $6000 | |
| PREFNAME | Preferred Name | Text | Char | $ | 1500 | $6000 | |
| PREFCODE | Preferred Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| PREFBASE | Preferred Base Code | Text | Char | $ | 1500 | $6000 | |
| PREFLABEL | Preferred Base | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
List of coding columns for JDrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| GDRUGNAME | Generic Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT1 | Drug Code Category 1 | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT2 | Drug Code Category 2 | Text | Char | $ | 1500 | $6000 | |
| USECAT1 | Use Category 1 | Text | Char | $ | 1500 | $6000 | |
| USECAT2 | Use Category 2 | Text | Char | $ | 1500 | $6000 | |
| MANNAME | Manufacturer Name | Text | Char | $ | 1500 | $6000 | |
| MANCODE | Manufacturer Code | Text | Char | $ | 1500 | $6000 | |
| MAINTFLG | Maintenance Flag | Text | Char | $ | 1500 | $6000 | |
| MAINTDT | Maintenance Date | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
Definitions File
The Study Data Extract ZIP file contains a definition file, which is a listing of all columns across all datasets included in the extract.
List of columns included in the Definitions file:
| Column Header | Data |
|---|---|
| Dataset Name | Name of the dataset |
| Column | Name of the column |
| Type | Item type for clinical data items |
| SAS Type | SAS type of the column |
| SAS Informat | SAS informat applied |
| SAS Format | SAS format applied |
| Length | Length in characters |
| SAS Length | SAS length in bytes |
| Label | SAS Label of the column |
System Datasets
Along with clinical datasets, the Study Data Extract file contains several system datasets that contain operational data and metrics.
SYS_SITE
The SYS_SITE dataset lists all sites for the selected study.
List of SYS_SITE columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Study Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SITENAME | Study Site Name | Text | Char | $ | 128 | $512 | ||
| INVNAME | Principal Investigator | Text | Char | $ | 128 | $512 | ||
| CASEBDEF | Casebook Version | Integer | Num | 14 | 8 | |||
| STATUS | Site Status | Text | Char | $ | 100 | $400 | ||
| TIMEZONE | Timezone of the Site | Text | Char | $ | 100 | $400 | ||
| BULKCASEBOOKSIGNATURE | Bulk Casebook Signature | Boolean | Char | $ | 5 | $20.00 | ||
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_SUB
The SYS_SUB dataset lists all subjects for the selected study.
List of SYS_SUB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| IXRSID | Subject IXRS ID | Text | Char | $ | 255 | $1020 | This column refers to an external Subject ID that may be set through API or Integration. | |
| CASEBDEF | Casebook Version | Integer | Num | 14 | 8 | |||
| STATUS | Status of the Subject/Casebook | Text | Char | $ | 100 | $400 | ||
| GUID | Internal Vault ID of the subject | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTMODDT | Subject Last Modified Datetime | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LATESTARM | Latest Arm | Text | Char | $ | 128 | $512 | ||
| LATESTCOHORT | Latest Cohort | Text | Char | $ | 128 | $512 | ||
| LATESTSUBSTUDY | Latest Substudy | Text | Char | $ | 128 | $512 | ||
| CNSNTDT | Initial Consent Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| LATESTARM | Latest Arm | Text | Char | $ | 128 | $512 | ||
| LATESTCOHORT | Latest Cohort | Text | Char | $ | 128 | $512 | ||
| LATEST SUBSTUDY | Latest Substudy | Text | Char | $ | 128 | $512 | ||
| SCRDDT | Screened date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| SCRFAILDT | Screen failed date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ENRDDT | Enrolled date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| RDMDDT | Randomized date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| STARTTRTDT | Started Treatment Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ENDTRTDT | End of treatment date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| WTHDRWNDT | Withdrawn date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| STARTFLLWUPDT | Started Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| LOSTFLLWUPDT | Lost to Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| CMPLTDT | End of study date | Date | Num | : vdate. | DATE9. | 14 | 8 |
SYS_EVT
The SYS_EVT dataset lists all events as well as event dates and status for the selected study.
List of SYS_EVT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9 | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| LASTMODDAT | Last modified date/time of the event date (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CASEBDEF | Casebook Version | Integer | Num | $ | 14 | 8 | ||
| STATUS | Status of the event/visit | Text | Char | $ | 100 | $400 | ||
| LASTREAS | Last change reason | Text | Char | $ | 255 | $1020 | ||
| WINSTAT | Scheduled Window Status | Text | Char | $ | 32 | $128 | ||
| DAYSOW | Days Outside Window | Integer | Num | 14 | 8 | |||
| EXPFORMS | Expected Number of Forms | Integer | Num | 14 | 8 | |||
| FORMEOD | Number of days past due when one or more forms is not yet complete | Integer | Num | 14 | 8 | |||
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_FORM
The SYS_FORM dataset lists all forms for the selected study, including forms Intentionally Left Blank as well as review statuses, freeze and lock statuses, and additional metrics.
List of SYS_FORM columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| STATUS | Form Status | Text | Char | $ | 100 | $400 | ||
| CREATEDT | Datetime form created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTSUBMITDT | Datetime form first submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | This field will only be populated for new studies created after 23R3. |
| LASTSUBMITDT | Datetime form last submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Number of times form was submitted | Integer | Num | 14 | 8 | |||
| SDVREQ | SDV Required | Boolean | Char | $ | 5 | $20 | Not supported for SDV rollup V1 studies, will be blank | |
| SDVDT | Datetime considered SDV complete (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTSDVDT | Datetime Form First SDV Complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| SDVLAST | Datetime of last SDV modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TOSDV | Days from submit to SDV | Float | Num | 14 | 8 | |||
| DMRREQ | DMR Required | Boolean | Char | $ | 5 | $20 | Not supported for SDV rollup V1 studies, will be blank | |
| DMRDT | Datetime considered DMR complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTDMRDT | Datetime Form First DMR Complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| DMRLAST | Datetime of last DMR modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TODMR | Days from submit to DMR | Float | Num | 14 | 8 | |||
| FREEZEDT | Datetime frozen (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOFREEZE | Days from submit to freeze | Float | Num | 14 | 8 | |||
| LOCKDT | Datetime locked (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOLOCK | Days from submit to lock | Float | Num | 14 | 8 | |||
| SIGNDT | Datetime signed (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LSTSGNDT | Last Signature Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOSIGN | Days from submit to sign | Float | Num | 14 | 8 | |||
| EDT_SUBM | Days from event date (of form) to submit date | Float | Num | 14 | 8 | |||
| ILB | Intentionally Left Blank | Boolean | Char | $ | 5 | $20 | ||
| ILBREAS | Reason for Intentionally Left Blank | Text | Char | $ | 255 | $1020 | ||
| GUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_Q
The SYS_Q dataset lists all queries for the selected study, along with some query metrics. Only the first query message is listed in this dataset. The full list of query messages (first message, answers, etc.) is included in the SYS_QT dataset.
List of SYS_Q columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | 512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGROUPDEF | Item Group Definition Name | Text | Char | $ | 128 | 512 | ||
| IGSEQ | Item group sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | 128 | $512 | |||
| QUERYID | Query ID | Text | Char | $ | 128 | $512 | ||
| STATUS | Query status | Text | Char | $ | 100 | $400 | Includes Open, Answered, and Closed queries. | |
| RESTRICTED | Query Restricted | Boolean | Char | 5 | $20 | Visible if "Include Restricted Data" is selected in SDE Version 23R1. | ||
| MANUAL | Manual query | Boolean | Char | $ | 5 | $20 | ||
| RULEID | Rule name | Text | Char | $ | 128 | $512 | ||
| TRIGID | Trigger name | Text | Char | $ | 128 | $512 | ||
| QTEXT | Initial query text/message | Text | Char | $ | 500 | $2000 | ||
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created by | Text | Char | $ | 201 | $804 | ||
| LASTCLOSEDDT | Query Last Closed Date | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| QUERYTEAM | Query team | Text | Char | $ | 50 | $200 | ||
| QTFRESP | Time to first response (days) | Float | Num | 14 | 8 | Only populated when there's a First Response Date and the query has a status of "Answered." | ||
| QAGE | Query Age (days) | Float | Num | 14 | 8 | |||
| QCHGDATA | Whether the data changed after query creation (field query attached) | Boolean | Char | $ | 5 | $20 | ||
| QOTOCL | Query open to close (days) | Float | Num | 14 | 8 | |||
| GUID | Internal Vault ID of the query | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_QT
The SYS_QT dataset lists all query messages for the selected study.
You can link the content of this file with the SYS_Q dataset using the QUERYID column. There can be multiple SYS_QT records matching one SYS_Q record (i.e. a query in SYS_Q can have multiple query messages in SYS_QT).
List of SYS_QT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| QUERYID | Query ID | Text | Char | $ | 128 | $512 | ||
| STATUS | Query status | Text | Char | $ | 100 | $400 | Includes Open, Answered, Closed, and Reopened queries | |
| RESTRICTED | Query Restricted | Boolean | Char | 5 | $20 | Visible if "Include Restricted Data" is selected in SDE Version 23R1. | ||
| QTEXT | Initial query text/message | Text | Char | $ | 500 | $2000 | ||
| TEXTDT | Text/Message Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TEXTBY | Text/Message By | Text | Char | $ | 201 | $1804 | ||
| QUERYTEAM | Query team | Text | Char | $ | 50 | $200 | ||
| GUID | Internal Vault ID of the query message | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ILB
The SYS_ILB dataset lists all items that have been marked Intentionally Left Blank in the selected study.
List of SYS_ILB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition Name | Text | Char | 128 | 512 | |||
| IGROUPEID | Item Group External ID | Text | Char | 128 | 512 | |||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | $ | 128 | $512 | ||
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | Visible if Local Labs is enabled | |
| ILBREAS | Reason for intentionally left blank | Text | Char | $ | 255 | $1020 | ||
| GUID | Internal Vault ID of the item/field | Text | Char | $ | 100 | $400 | For HVO objects (item2__v), the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LINKS
The SYS_LINKS dataset lists all forms that belong to a form link in the selected study. Forms that are linked together will share the same link ID, which will display in the GUID column. The form unique identifier (FGUID) can then be used to identify a specific form and access its data.
List of SYS_LINKS columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Description |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form external ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | Only visible if Form Linking is enabled. | |
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | Only visible if Form Linking is enabled. | |
| ITEMEID | Item External ID | Text | Char | 128 | $512 | Only visible if Form Linking is enabled. | ||
| FORMCREATEDDT | Form Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LINKCREATEDDT | Link Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created by | Text | Char | $ | 201 | $804 | ||
| FGUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| GUID | Internal Link ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASM
The SYS_ASM dataset lists the following information about assessments, if assessments are configured for a Study.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| SOURCEF | Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| SOURCEFEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| ASMNAME | Assessment Name | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| ASMEID | Assessment External ID | Text | Char | $ | 128 | $512 | ||
| ASMTYPE | Assessment Type | Text | Char | $ | 128 | $512 | ||
| REASSESSMENT | Reassessment | Boolean | Char | $ | 5 | $20 | ||
| SOURCEF | Source Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| STATUS | Status of Assessment | Text | Char | $ | 100 | $400 | ||
| SOURCEFRESTRICTED | Source Form Restricted | Boolean | Char | $ | 5 | $20 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| COMPDT | Completed Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Submit Count | Integer | Num | 14 | 8 | |||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| GUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| FGUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASMR
The SYS_ASMR dataset lists questions and answers for all assessments in a Study, if assessments are configured.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| SOURCEF | Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| SOURCEFEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| QUESNUM | Question Number | Integer | Num | 14 | 8 | |||
| ASMNAME | Assessment Name | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| ASMEID | Assessment External ID | Text | Char | $ | 128 | $512 | ||
| QUESTEXT | Question Text | Text | Char | $ | 128 | $512 | ||
| QUESTEXTDEF | Question Text Definition | Text | Char | $ | 128 | $512 | ||
| QUESEID | Question External ID | Text | Char | $ | 128 | $512 | ||
| QUESANS | Question Answer | Text | Char | $ | 1500 | $6000 | ||
| SOURCEFRESTRICTED | Source Form Restricted | Boolean | Char | $ | 5 | $20 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| AGUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_PD
The SYS_PD dataset lists the following Protocol Deviations information, if Protocol Deviations is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Description |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| PDID | Protocol Deviation Identifier | Text | Char | $ | 128 | $512 | ||
| PDSUM | Protocol Deviation Summary | Text | Char | $ | 250 | $1000 | ||
| PDDAT | Date of Deviation | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDDATID | Date Identified | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDCAT | Category | Text | Char | $ | 128 | $512 | ||
| PDCATLABEL | Category Label | Text | Char | $ | 128 | $512 | ||
| PDSUBCAT | Subcategory | Text | Char | $ | 128 | $512 | ||
| PDSUBCATLABEL | Subcategory Label | Text | Char | $ | 128 | $512 | ||
| PDSEV | Severity | Text | Char | $ | 128 | $512 | ||
| PDSEVLABEL | Severity Label | Text | Char | $ | 128 | $512 | ||
| PDDESC | Description | Text | Char | $ | 500 | $2000 | ||
| PDSTATUS | Protocol Deviation Status | Text | Char | $ | 100 | $400 | ||
| PDRES | Protocol Deviation Resolution | Text | Char | $ | 500 | $2000 | ||
| PDRULE | Protocol Deviation Rule | Text | Char | $ | 128 | $512 | ||
| RESTRICTED | Protocol Deviation Restricted | Boolean | Char | 5 | $20 | |||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | 128 | $512 | |||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| USERMODDT | User Modified Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| USERMODB | User Modified By | Text | Char | $ | 201 | $804 | ||
| INACBYSYS | Inactivated by System | Boolean | Char | $ | 5 | $20 | ||
| LASTINACDT | Last Inactivated Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID of Form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| PDGUID | Internal Vault ID of Protocol Deviation | Text | Char | $ | 15 | $60 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_RAND
The SYS_RAND dataset lists the following Randomization information, if Randomization is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITE | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| RANDSTATUS | Randomization Status | Text | Char | $ | 100 | $400 | ||
| RANDID | Randomization ID | Text | Char | $ | 128 | $512 | ||
| TREATMENTNAME* | Treatment Name | Text | Char | $ | 128 | $512 | ||
| TREATMENTLABEL* | Treatment Label | Text | Char | $ | 1500 | $6000 | ||
| TREATMENTARM* | Treatment Arm | Text | Char | $ | 128 | $512 | Visible if "Include Randomization Treatment" is selected in SDE Version 22R1 or later | |
| RANDSTRATA | Strata Group | Text | Char | $ | 128 | $512 | ||
| RANDBY | Randomized By | Text | Char | $ | 201 | $804 | ||
| RANDDAT | Randomized Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| RANDFILE | Randomization File Label | Text | Char | $ | 128 | $512 | ||
| RANDFILEDAT | Randomization File Upload Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
*These columns are only available for unmasked studies with Randomization enabled and users with the View Unmasked Data and View Randomization Enrollment permissions. To include these columns, check the Include Randomization Treatment box in the New Job dialog. Note that you can’t download SDE files from users with the View Randomization Enrollment permission if the Include Randomization Treatment checkbox is not visible to you in the SDE job dialog.
SYS_LABRANGES
The SYS_LABRANGES dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | |
| LABLOC | Lab Location | Text | Char | $ | 128 | $512 | |
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | |
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 128 | $512 | |
| LABREFRSTATUS | Lab Reference Range Status | Text | Char | $ | 100 | $400 | |
| LABTESTCODE | Test Code | Text | Char | $ | 128 | $512 | |
| LABSEX | Sex | Text | Char | $ | 128 | $512 | |
| LABLOWERAGE | Lower Age | Integer | Num | 14 | 8 | ||
| LABUPPERAGE | Upper Age | Integer | Num | 14 | 8 | ||
| LABAGEUNIT | Age Unit | Text | Char | $ | 128 | $512 | |
| LABFEMCYCLE | Female Cycle | Text | Char | $ | 128 | $512 | |
| LABLNORMAL | Lower Normal | Float | Num | 14 | 8 | ||
| LABUNORMAL | Upper Normal | Float | Num | 14 | 8 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 128 | $512 | |
| LABMEASUNITLABEL | Measurement Unit Label | Text | Char | $ | 128 | $512 | |
| LABCODENORM | Codelist Normal | Text | Char | $ | 128 | $512 | |
| LABTEXTNORM | Text Normal | Text | Char | $ | 3000 | $12000 | |
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | $20 | |
| LABFROMDT | Effective From Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABTODT | Effective To Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABDESCR | Description | Text | Char | $ | 500 | $2000 | |
| LABSPECTYPE | Specimen Type | Text | Char | $ | 128 | $512 | |
| LABTESTMET | Testing Method | Text | Char | $ | 128 | $512 | |
| CREATB | Created By | Text | Char | $ | 201 | $804 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LABLOC
The SYS_LABLOC dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | ||
| LABLOC | Lab Location | Text | Char | $ | 128 | $512 | ||
| LABLOCSTATUS | Lab Location Status | Text | Char | $ | 100 | $400 | ||
| LABAPPROVED | Approved Lab Location | Text | Char | $ | 128 | $512 | ||
| LABADDRESS | Lab Address | Text | Char | $ | 500 | $2000 | ||
| LABCOUNTRY | Lab Country | Text | Char | $ | 128 | $512 | ||
| LABCONTACT | Lab Contact Name | Text | Char | $ | 128 | $512 | ||
| LABCONTITLE | Lab Contact Title | Text | Char | $ | 128 | $512 | ||
| LABTEL | Lab Telephone | Text | Char | $ | 40 | $160 | ||
| LABFAX | Lab Fax | Text | Char | $ | 40 | $160 | ||
| LABPRIMEMAIL | Lab Primary Email | Text | Char | $ | 80 | $320 | ||
| LABSECMAIL | Lab Secondary Email | Text | Char | $ | 80 | $320 | ||
| LABSTATUS | Lab Status | Text | Char | $ | 100 | $400 | ||
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ANALYTES
The SYS_ANALYTES dataset lists the following Labs analyte information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | ||
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 128 | $512 | ||
| LABDESCR | Description | Text | Char | $ | 500 | $2000 | ||
| LABDATATYPE | Data Type | Text | Char | $ | 100 | $400 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 128 | $512 | ||
| LABCODELIST | Codelist | Text | Char | $ | 128 | $512 | ||
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | $20 | ||
| LABSPECTYPE | Specimen Type | Text | Char | $ | 128 | $512 | ||
| LABLEN | Length | Integer | Num | 14 | 8 | |||
| LABPREC | Precision | Integer | Num | 14 | 8 | |||
| LABSYSMANAGED | System Managed | Boolean | Char | $ | 5 | $20 | ||
| LABTESTMET | Testing Method | Text | Char | $ | 128 | $512 | ||
| LABLOINC | LOINC Code | Text | Char | $ | 128 | $512 | ||
| LABSDTMNM | SDTM Name | Text | Char | $ | 255 | $1020 | ||
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
23R2 Version
Clinical Datasets
Each clinical dataset, and each Form (Adverse Events, Concomitant Medications, etc.), contains a set of Key Columns and a set of Clinical Data columns, which are detailed below.
Key Columns
Key Columns contain data to help identify which Form each row is referring to (ex: which Subject, Site, Cycle, or Event that particular form is located in).
The list of Key Columns is as follows:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | This column refers to study_label or study in the API. | |
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | 512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| VISMETHOD | Visit Method | Text | Char | $ | 100 | $400 | This column is only visible if Visit Method is enabled. | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| FORMSTATUS | Form Status | Text | Char | 100 | 400 | |||
| CREATEDT | Datetime Form Created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTSUBMITDT | Datetime Form First Submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | This field will only be populated for new studies created after 23R3. |
| LASTSUBMITDT | Datetime Form Last Submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| DLASTMOD | Datetime of last data change (UTC). This field is derived by taking the most recent datetime from all of the items' value_modified_date__v on the form. | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Datetime columns can be separated into two separate Date and Time columns. |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| IGGUID | Internal Vault ID (item groups) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| FORMILB | Intentionally Left Blank | Boolean | Char | $ | 5 | $20 | ||
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (Form Link ItemDef Name)_DEF | [Form Link Item Label] Definition | Text | Char | $ | 200 | $800 | If Item to Form Linking is enabled. Format of the cell value: Form Label that is linked to the item. The Form Sequence (#X) is included if the form is repeating. | |
| (Form Link ItemDef Name)_LINKEDFORMID | [Form Link Item Label] Linked Form ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled. | |
| (Form Link ItemDef Name)_LINKID | [Form Link Item Label] Link ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled. | |
| LINKEDTO 1 | Links to other forms | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| ITEMLINKEDTO 2 | Item Linked To | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| LINKEDITEM | Linked Item | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| (ITEMNAME) | (Item Label) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_UTC | (Item Label)_UTC | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_USER | (Item Label)_User | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
|
1 This column displays in the following format: 2 This column displays in the following format: |
||||||||
*This column displays in the following format:
X Form(s): <Form Definition Label> [Form Definition Name] (#Y) – <Item Name 1> = <Item Value 1>, <Item Name 2> = <Item Value 2>, <Item Name 3> = <Item Value 3>
- X = total number of linked forms
- Y = number that is incremented
This format shows up to 3 items on the form, up to the maximum character limit.
Clinical Data
After the Key Columns, the system will insert Clinical Data columns, with each column representing an item on the Form.
Clinical Data Item Headers use the item names or external ID defined in Studio. Some items can be associated with more than one column, depending on their data type:
- Codelists are split into two columns:
- ITEMNAME: this column contains the codelist code
- ITEMNAME_D: this column contains the codelist decode or label
- Units are split into four columns:
- ITEMNAME: this column contains the value entered in the item
- ITEMNAME_U: this column contains the unit entered in the item
- ITEMNAME_TRANS: this column contains the “translated” item value, which is the value that was entered that has been converted to the standard unit
- ITEMNAME_TRANSU: this column contains the standard unit
- Datetimes are split into three columns:
- ITEMNAME: this column contains the datetime value entered (site’s timezone)
- ITEMNAME_UTC: this column contains the datetime value converted to UTC
- ITEMNAME_USER: this column contains the datetime value converted to the timezone of the user running the Study Data Extract
Unknown parts in dates and datetimes are represented by UN in ISO format:
- For a date: 2021-UN-UN
- For a datetime: 2021-UN-TUN:UN:UN.UNKZ
You can choose from the following Clinical Data options:
| Option | Description |
|---|---|
| Use Item External ID instead of Item Name for column headers | Replaces the column headers in the clinical datasets (which currently use the Item Name) with the Item External ID configured in Studio |
| Include Separate Date and Time columns for Datetime items | Creates two additional columns with the postfixes (Item)_DT and (Item)_TM for the Date and Time of the Datetime item |
| Include forms Intentionally Left Blank | Creates a column in the clinical datasets called FORMILB that indicates whether the form has been marked Intentionally Left Blank in clinical datasets (default behavior is to skip rows) |
| Exclude blank forms | Excludes forms whose status = "Blank" in the clinical datasets. Note that these forms will still appear in the SYS_FORM dataset |
Casebook Versions
All casebook versions are displayed in Study Data Extracts, so items that were deleted from the schedule in subsequent casebook versions will still appear in Clinical Datasets. This inclusion guarantees that all data is extracted, even if certain subjects were kept on a previous casebook version.
The Study Data Extract job first adds columns for all items that are present in Casebook Version 1 before adding columns for any items that may have been added in subsequent casebook versions to create the Study Data Extract file.
Lab Columns
Each form configured with Local Labs contains certain columns that are dynamically added after the LASTRUN column for lab items. Refer to the table below for a complete list of columns.
23R1 Version Lab Format Change: Clinical forms that are configured with Local Labs are formatted to decrease the number of columns outputted in SDE Version 23R1. In this version, Labs columns are shared across all analytes on the form instead of using multiple columns per analyte. See the SDE Versioning page for the list of Labs columns included in previous SDE versions.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | 128 | $512 | |||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | :vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| DLASTMOD | Datetime of last data change (UTC) | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| IGGUID | Internal Vault ID (Item Groups) | Text | Char | $ | 15 | $60 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| LBDTC | Collection Date Time | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBDTC_UTC | Collection Date Time_UTC | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBDTC_USER | Collection Date Time_USER | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBLOC | Lab Location* | Text | Char | $ | 128 | $512 | ||
| LBAGE | Age | Integer | Num | 14 | 8 | |||
| LBAGE_U | Age_U | Text | Char | 128 | $512 | |||
| LBAGE_TRANS | Age_TRANS | Integer | Num | 14 | 8 | |||
| LBAGE_TRANSU | Age_TRANSU | Text | Char | $ | 128 | $512 | ||
| LBTEST | Lab Test | Text | Char | $ | 128 | $512 | ||
| LABMODIFIER | Lab Modifier | Text | Char | $ | 128 | $512 | Visible for Studies using Global (Versionless) Labs if at least one analyte definition has Lab Modifiers configured. | |
| LABMODIFIER_D | Lab Modifier_D | Text | Char | $ | 256 | $1024 | Visible for Studies using Global (Versionless) Labs if at least one analyte definition has Lab Modifiers configured. | |
| LBORRES | Lab Result | Text, Float, or Integer | Char or Num | $ | 1500 or 14 | $6000 or 8 | Data type may be float or integer if all cells in that column have the same data type. Note that if the data type is float or integer, the length/SAS length may change to the default for numeric values. | |
| LBORRES_U_D | Lab Result Unit or Decode for Codelists and Units | Text | Char | $ | 1500 | $6000 | Visible for Unit, Number, Codelist, or Text analyte type. | |
| LBORRES_TRANS | Lab Result_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORRES_TRANSU | Lab Result_TRANSU | Text | Char | $ | 1500 | $6000 | ||
| LBORNRLO | Normal Range Lower Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRHI | Normal Range Upper Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRLOHI_U | Normal Range Lower and Upper Limit_U | Text | Char | $ | 1500 | $6000 | ||
| LBORNRLO_TRANS | Normal Range Lower Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRHI_TRANS | Normal Range Upper Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRLOHI_TRANSU | Normal Range Lower and Upper Limit_TRANSU | Text | Char | $ | 1500 | $6000 | ||
| LBOVRDNRLO | Normal Range Override Lower Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDNRHI | Normal Range Override Upper Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDNRLOHI_U | Normal Range Override Lower and Upper Limit_U | Text | Char | $ | 1500 | $6000 | ||
| LBOVRDNRLO_TRANS | Normal Range Override Lower Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDRLOHI_TRANSU | Normal Range Override Lower and Upper Limit_TRANSU | Text | Char | $ | 1500 | $6000 | Data type may be integer if all cells in that column are integers. | |
| LBSTNRC | Normal Value | Text | Char | $ | 1500 | $6000 | For Codelist or Text-type Analytes. | |
| LBSTNRC_D | Normal Value_D | Text | Char | $ | 256 | $1024 | For Codelist-type Analytes. | |
| LBOVRDNRC | Normal Value Override | Text | Char | $ | 1500 | $6000 | For Codelist or Text-type Analytes. | |
| LBOVRDNRC_D | Normal Value Override_D | Text | Char | $ | 256 | $1024 | For Codelist-type Analytes. | |
| LBNRIND | Normal Range Indicator | Text | Char | $ | 1500 | $6000 | ||
| LBCLSIG | Clinical Significance | Text | Char | $ | 1500 | $6000 |
*This field refers to the Lab ID.
The LBDTC, LBLOC, and LBAGE columns are part of the Lab Header that is generated for each lab form. Each column related to a Lab Analyte with a “Unit” type has additional columns for the Unit (appended with _U), the Translated Value (appended with _TRANS), and the Translated Unit (appended with _TRANSU). For example, the Lab Result Unit for Sodium would display in the column header as LBORRES_Sodium_U.
Coding Data
If a form is set up for coding, meaning that a coding configuration has been defined in Studio, coding-related columns will be added after clinical data columns. If there are multiple verbatims set up in a form, the system will add a set of coding columns for each verbatim configured. If the same item in different item groups is configured for coding, the system will add “itemgroup.item” to each column header to indicate which set of columns belongs to which verbatim. Note that you need the View Code permission to view coding columns in the SDE.
List of coding columns for MedDRA:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| SOC | SOC | Text | Char | $ | 1500 | $6000 | |
| SOCID | SOC Code | Text | Char | $ | 1500 | $6000 | |
| HLGT | HLGT | Text | Char | $ | 1500 | $6000 | |
| HLGTID | HLGT Code | Text | Char | $ | 1500 | $6000 | |
| HLT | HLT | Text | Char | $ | 1500 | $6000 | |
| HLTID | HLT Code | Text | Char | $ | 1500 | $6000 | |
| PT | PT | Text | Char | $ | 1500 | $6000 | |
| PTID | PT Code | Text | Char | $ | 1500 | $6000 | |
| LLT | LLT | Text | Char | $ | 1500 | $6000 | |
| LLTID | LLT Code | Text | Char | $ | 1500 | $6000 | |
| PRIMPATH | Primary Path | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
List of coding columns for WHODrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| ATC1 | ATC1 | Text | Char | $ | 1500 | $6000 | |
| ATC1CD | ATC1 Code | Text | Char | $ | 1500 | $6000 | |
| ATC2 | ATC2 | Text | Char | $ | 1500 | $6000 | |
| ATC2CD | ATC2 Code | Text | Char | $ | 1500 | $6000 | |
| ATC3 | ATC3 | Text | Char | $ | 1500 | $6000 | |
| ATC3CD | ATC3 Code | Text | Char | $ | 1500 | $6000 | |
| ATC4 | ATC4 | Text | Char | $ | 1500 | $6000 | |
| ATC4CD | ATC4 Code | Text | Char | $ | 1500 | $6000 | |
| PREFNAME | Preferred Name | Text | Char | $ | 1500 | $6000 | |
| PREFCODE | Preferred Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| PREFBASE | Preferred Base Code | Text | Char | $ | 1500 | $6000 | |
| PREFLABEL | Preferred Base | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
List of coding columns for JDrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| GDRUGNAME | Generic Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT1 | Drug Code Category 1 | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT2 | Drug Code Category 2 | Text | Char | $ | 1500 | $6000 | |
| USECAT1 | Use Category 1 | Text | Char | $ | 1500 | $6000 | |
| USECAT2 | Use Category 2 | Text | Char | $ | 1500 | $6000 | |
| MANNAME | Manufacturer Name | Text | Char | $ | 1500 | $6000 | |
| MANCODE | Manufacturer Code | Text | Char | $ | 1500 | $6000 | |
| MAINTFLG | Maintenance Flag | Text | Char | $ | 1500 | $6000 | |
| MAINTDT | Maintenance Date | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
Definitions File
The Study Data Extract ZIP file contains a definition file, which is a listing of all columns across all datasets included in the extract.
List of columns included in the Definitions file:
| Column Header | Data |
|---|---|
| Dataset Name | Name of the dataset |
| Column | Name of the column |
| Type | Item type for clinical data items |
| SAS Type | SAS type of the column |
| SAS Informat | SAS informat applied |
| SAS Format | SAS format applied |
| Length | Length in characters |
| SAS Length | SAS length in bytes |
| Label | SAS Label of the column |
System Datasets
Along with clinical datasets, the Study Data Extract file contains several system datasets that contain operational data and metrics.
SYS_SITE
The SYS_SITE dataset lists all sites for the selected study.
List of SYS_SITE columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Study Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SITENAME | Study Site Name | Text | Char | $ | 128 | $512 | ||
| INVNAME | Principal Investigator | Text | Char | $ | 128 | $512 | ||
| CASEBDEF | Casebook Version | Integer | Num | 14 | 8 | |||
| STATUS | Site Status | Text | Char | $ | 100 | $400 | ||
| TIMEZONE | Timezone of the Site | Text | Char | $ | 100 | $400 | ||
| BULKCASEBOOKSIGNATURE | Bulk Casebook Signature | Boolean | Char | $ | 5 | $20.00 | ||
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_SUB
The SYS_SUB dataset lists all subjects for the selected study.
List of SYS_SUB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| IXRSID | Subject IXRS ID | Text | Char | $ | 255 | $1020 | This column refers to an external Subject ID that may be set through API or Integration. | |
| CASEBDEF | Casebook Version | Integer | Num | 14 | 8 | |||
| STATUS | Status of the Subject/Casebook | Text | Char | $ | 100 | $400 | ||
| GUID | Internal Vault ID of the subject | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTMODDT | Subject Last Modified Datetime | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CNSNTDT | Initial Consent Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| SCRDDT | Screened date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| SCRFAILDT | Screen failed date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ENRDDT | Enrolled date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| RDMDDT | Randomized date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| STARTTRTDT | Started Treatment Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ENDTRTDT | End of treatment date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| WTHDRWNDT | Withdrawn date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| STARTFLLWUPDT | Started Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| LOSTFLLWUPDT | Lost to Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| CMPLTDT | End of study date | Date | Num | : vdate. | DATE9. | 14 | 8 |
SYS_EVT
The SYS_EVT dataset lists all events as well as event dates and status for the selected study.
List of SYS_EVT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9 | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| LASTMODDAT | Last modified date/time of the event date (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CASEBDEF | Casebook Version | Integer | Num | $ | 14 | 8 | ||
| STATUS | Status of the event/visit | Text | Char | $ | 100 | $400 | ||
| LASTREAS | Last change reason | Text | Char | $ | 255 | $1020 | ||
| WINSTAT | Scheduled Window Status | Text | Char | $ | 32 | $128 | ||
| DAYSOW | Days Outside Window | Integer | Num | 14 | 8 | |||
| EXPFORMS | Expected Number of Forms | Integer | Num | 14 | 8 | |||
| FORMEOD | Number of days past due when one or more forms is not yet complete | Integer | Num | 14 | 8 | |||
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_FORM
The SYS_FORM dataset lists all forms for the selected study, including forms Intentionally Left Blank as well as review statuses, freeze and lock statuses, and additional metrics.
List of SYS_FORM columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| STATUS | Form Status | Text | Char | $ | 100 | $400 | ||
| CREATEDT | Datetime form created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| SUBMITDT | Datetime form last submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Number of times form was submitted | Integer | Num | 14 | 8 | |||
| SDVREQ | SDV Required | Boolean | Char | $ | 5 | $20 | Not supported for SDV rollup V1 studies, will be blank | |
| SDVDT | Datetime considered SDV complete (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| SDVLAST | Datetime of last SDV modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TOSDV | Days from submit to SDV | Float | Num | 14 | 8 | |||
| DMRREQ | DMR Required | Boolean | Char | $ | 5 | $20 | Not supported for SDV rollup V1 studies, will be blank | |
| DMRDT | Datetime considered DMR complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| DMRLAST | Datetime of last DMR modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TODMR | Days from submit to DMR | Float | Num | 14 | 8 | |||
| FREEZEDT | Datetime frozen (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOFREEZE | Days from submit to freeze | Float | Num | 14 | 8 | |||
| LOCKDT | Datetime locked (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOLOCK | Days from submit to lock | Float | Num | 14 | 8 | |||
| SIGNDT | Datetime signed (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LSTSGNDT | Last Signature Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOSIGN | Days from submit to sign | Float | Num | 14 | 8 | |||
| EDT_SUBM | Days from event date (of form) to submit date | Float | Num | 14 | 8 | |||
| ILB | Intentionally Left Blank | Boolean | Char | $ | 5 | $20 | ||
| ILBREAS | Reason for Intentionally Left Blank | Text | Char | $ | 255 | $1020 | ||
| GUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_Q
The SYS_Q dataset lists all queries for the selected study, along with some query metrics. Only the first query message is listed in this dataset. The full list of query messages (first message, answers, etc.) is included in the SYS_QT dataset.
List of SYS_Q columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | 512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| ITEMGROUP | Item group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition Name | Text | Char | $ | 128 | 512 | ||
| IGSEQ | Item group sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | 128 | $512 | |||
| QUERYID | Query ID | Text | Char | $ | 128 | $512 | ||
| STATUS | Query status | Text | Char | $ | 100 | $400 | Includes Open, Answered, and Closed queries. | |
| RESTRICTED | Query Restricted | Boolean | Char | 5 | $20 | Visible if "Include Restricted Data" is selected in SDE Version 23R1. | ||
| MANUAL | Manual query | Boolean | Char | $ | 5 | $20 | ||
| RULEID | Rule name | Text | Char | $ | 128 | $512 | ||
| TRIGID | Trigger name | Text | Char | $ | 128 | $512 | ||
| QTEXT | Initial query text/message | Text | Char | $ | 500 | $2000 | ||
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created by | Text | Char | $ | 201 | $804 | ||
| LASTCLOSEDDT | Query Last Closed Date | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| QUERYTEAM | Query team | Text | Char | $ | 50 | $200 | ||
| QTFRESP | Time to first response (days) | Float | Num | 14 | 8 | Only populated when there's a First Response Date and the query has a status of "Answered." | ||
| QAGE | Query Age (days) | Float | Num | 14 | 8 | |||
| QCHGDATA | Whether the data changed after query creation (field query attached) | Boolean | Char | $ | 5 | $20 | ||
| QOTOCL | Query open to close (days) | Float | Num | 14 | 8 | |||
| GUID | Internal Vault ID of the query | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_QT
The SYS_QT dataset lists all query messages for the selected study.
You can link the content of this file with the SYS_Q dataset using the QUERYID column. There can be multiple SYS_QT records matching one SYS_Q record (i.e. a query in SYS_Q can have multiple query messages in SYS_QT).
List of SYS_QT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| QUERYID | Query ID | Text | Char | $ | 128 | $512 | ||
| STATUS | Query status | Text | Char | $ | 100 | $400 | Includes Open, Answered, Closed, and Reopened queries | |
| RESTRICTED | Query Restricted | Boolean | Char | 5 | $20 | Visible if "Include Restricted Data" is selected in SDE Version 23R1. | ||
| QTEXT | Initial query text/message | Text | Char | $ | 500 | $2000 | ||
| TEXTDT | Text/Message Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TEXTBY | Text/Message By | Text | Char | $ | 201 | $1804 | ||
| QUERYTEAM | Query team | Text | Char | $ | 50 | $200 | ||
| GUID | Internal Vault ID of the query message | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ILB
The SYS_ILB dataset lists all items that have been marked Intentionally Left Blank in the selected study.
List of SYS_ILB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition Name | Text | Char | 128 | 512 | |||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | $ | 128 | $512 | ||
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | Visible if Local Labs is enabled | |
| ILBREAS | Reason for intentionally left blank | Text | Char | $ | 255 | $1020 | ||
| GUID | Internal Vault ID of the item/field | Text | Char | $ | 100 | $400 | For HVO objects (item2__v), the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LINKS
The SYS_LINKS dataset lists all forms that belong to a form link in the selected study. Forms that are linked together will share the same link ID, which will display in the GUID column. The form unique identifier (FGUID) can then be used to identify a specific form and access its data.
List of SYS_LINKS columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form external ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | Only visible if Form Linking is enabled. | |
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | Only visible if Form Linking is enabled. | |
| ITEMEID | Item External ID | Text | Char | 128 | $512 | Only visible if Form Linking is enabled. | ||
| FORMCREATEDDT | Form Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LINKCREATEDDT | Link Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created by | Text | Char | $ | 201 | $804 | ||
| FGUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| GUID | Internal Link ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASM
The SYS_ASM dataset lists the following information about assessments, if assessments are configured for a Study.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| ASMNAME | Assessment Name | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| ASMEID | Assessment External ID | Text | Char | $ | 128 | $512 | ||
| ASMTYPE | Assessment Type | Text | Char | $ | 128 | $512 | ||
| REASSESSMENT | Reassessment | Boolean | Char | $ | 5 | $20 | ||
| SOURCEF | Source Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| STATUS | Status of Assessment | Text | Char | $ | 100 | $400 | ||
| SOURCEFRESTRICTED | Source Form Restricted | Boolean | Char | $ | 5 | $20 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| COMPDT | Completed Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Submit Count | Integer | Num | 14 | 8 | |||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| GUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| FGUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASMR
The SYS_ASMR dataset lists questions and answers for all assessments in a Study, if assessments are configured.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| ASMNAME | Assessment Name | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| ASMEID | Assessment External ID | Text | Char | $ | 128 | $512 | ||
| QUESTEXT | Question Text | Text | Char | $ | 128 | $512 | ||
| QUESTEXTDEF | Question Text Definition | Text | Char | $ | 128 | $512 | ||
| QUESANS | Question Answer | Text | Char | $ | 1500 | $6000 | ||
| SOURCEFRESTRICTED | Source Form Restricted | Boolean | Char | $ | 5 | $20 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| AGUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_PD
The SYS_PD dataset lists the following Protocol Deviations information, if Protocol Deviations is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| PDID | Protocol Deviation Identifier | Text | Char | $ | 128 | $512 | ||
| PDSUM | Protocol Deviation Summary | Text | Char | $ | 250 | $1000 | ||
| PDDAT | Date of Deviation | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDDATID | Date Identified | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDCAT | Category | Text | Char | $ | 128 | $512 | ||
| PDCATLABEL | Category Label | Text | Char | $ | 128 | $512 | ||
| PDSUBCAT | Subcategory | Text | Char | $ | 128 | $512 | ||
| PDSUBCATLABEL | Subcategory Label | Text | Char | $ | 128 | $512 | ||
| PDSEV | Severity | Text | Char | $ | 128 | $512 | ||
| PDSEVLABEL | Severity Label | Text | Char | $ | 128 | $512 | ||
| PDDESC | Description | Text | Char | $ | 500 | $2000 | ||
| PDSTATUS | Protocol Deviation Status | Text | Char | $ | 100 | $400 | ||
| PDRES | Protocol Deviation Resolution | Text | Char | $ | 500 | $2000 | ||
| PDRULE | Protocol Deviation Rule | Text | Char | $ | 128 | $512 | ||
| RESTRICTED | Protocol Deviation Restricted | Boolean | Char | 5 | $20 | |||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | 128 | $512 | |||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| USERMODDT | User Modified Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| USERMODB | User Modified By | Text | Char | $ | 201 | $804 | ||
| INACBYSYS | Inactivated by System | Boolean | Char | $ | 5 | $20 | ||
| LASTINACDT | Last Inactivated Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID of Form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| PDGUID | Internal Vault ID of Protocol Deviation | Text | Char | $ | 15 | $60 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_RAND
The SYS_RAND dataset lists the following Randomization information, if Randomization is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITE | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| RANDSTATUS | Randomization Status | Text | Char | $ | 100 | $400 | ||
| RANDID | Randomization ID | Text | Char | $ | 128 | $512 | ||
| TREATMENTNAME* | Treatment Name | Text | Char | $ | 128 | $512 | ||
| TREATMENTLABEL* | Treatment Label | Text | Char | $ | 1500 | $6000 | ||
| TREATMENTARM* | Treatment Arm | Text | Char | $ | 128 | $512 | Visible if "Include Randomization Treatment" is selected in SDE Version 22R1 or later | |
| RANDSTRATA | Strata Group | Text | Char | $ | 128 | $512 | ||
| RANDBY | Randomized By | Text | Char | $ | 201 | $804 | ||
| RANDDAT | Randomized Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| RANDFILE | Randomization File Label | Text | Char | $ | 128 | $512 | ||
| RANDFILEDAT | Randomization File Upload Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
*These columns are only available for unmasked studies with Randomization enabled and users with the View Unmasked Data and View Randomization Enrollment permissions. To include these columns, check the Include Randomization Treatment box in the New Job dialog. Note that you can’t download SDE files from users with the View Randomization Enrollment permission if the Include Randomization Treatment checkbox is not visible to you in the SDE job dialog.
SYS_LABRANGES
The SYS_LABRANGES dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | |
| LABLOC | Lab Location | Text | Char | $ | 128 | $512 | |
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | |
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 128 | $512 | |
| LABREFRSTATUS | Lab Reference Range Status | Text | Char | $ | 100 | $400 | |
| LABTESTCODE | Test Code | Text | Char | $ | 128 | $512 | |
| LABSEX | Sex | Text | Char | $ | 128 | $512 | |
| LABLOWERAGE | Lower Age | Integer | Num | 14 | 8 | ||
| LABUPPERAGE | Upper Age | Integer | Num | 14 | 8 | ||
| LABAGEUNIT | Age Unit | Text | Char | $ | 128 | $512 | |
| LABFEMCYCLE | Female Cycle | Text | Char | $ | 128 | $512 | |
| LABLNORMAL | Lower Normal | Float | Num | 14 | 8 | ||
| LABUNORMAL | Upper Normal | Float | Num | 14 | 8 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 128 | $512 | |
| LABMEASUNITLABEL | Measurement Unit Label | Text | Char | $ | 128 | $512 | |
| LABCODENORM | Codelist Normal | Text | Char | $ | 128 | $512 | |
| LABTEXTNORM | Text Normal | Text | Char | $ | 3000 | $12000 | |
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | $20 | |
| LABFROMDT | Effective From Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABTODT | Effective To Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABDESCR | Description | Text | Char | $ | 500 | $2000 | |
| LABSPECTYPE | Specimen Type | Text | Char | $ | 128 | $512 | |
| LABTESTMET | Testing Method | Text | Char | $ | 128 | $512 | |
| CREATB | Created By | Text | Char | $ | 201 | $804 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LABLOC
The SYS_LABLOC dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | ||
| LABLOC | Lab Location | Text | Char | $ | 128 | $512 | ||
| LABLOCSTATUS | Lab Location Status | Text | Char | $ | 100 | $400 | ||
| LABAPPROVED | Approved Lab Location | Text | Char | $ | 128 | $512 | ||
| LABADDRESS | Lab Address | Text | Char | $ | 500 | $2000 | ||
| LABCOUNTRY | Lab Country | Text | Char | $ | 128 | $512 | ||
| LABCONTACT | Lab Contact Name | Text | Char | $ | 128 | $512 | ||
| LABCONTITLE | Lab Contact Title | Text | Char | $ | 128 | $512 | ||
| LABTEL | Lab Telephone | Text | Char | $ | 40 | $160 | ||
| LABFAX | Lab Fax | Text | Char | $ | 40 | $160 | ||
| LABPRIMEMAIL | Lab Primary Email | Text | Char | $ | 80 | $320 | ||
| LABSECMAIL | Lab Secondary Email | Text | Char | $ | 80 | $320 | ||
| LABSTATUS | Lab Status | Text | Char | $ | 100 | $400 | ||
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ANALYTES
The SYS_ANALYTES dataset lists the following Labs analyte information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | ||
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 128 | $512 | ||
| LABDESCR | Description | Text | Char | $ | 500 | $2000 | ||
| LABDATATYPE | Data Type | Text | Char | $ | 100 | $400 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 128 | $512 | ||
| LABCODELIST | Codelist | Text | Char | $ | 128 | $512 | ||
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | $20 | ||
| LABSPECTYPE | Specimen Type | Text | Char | $ | 128 | $512 | ||
| LABLEN | Length | Integer | Num | 14 | 8 | |||
| LABPREC | Precision | Integer | Num | 14 | 8 | |||
| LABSYSMANAGED | System Managed | Boolean | Char | $ | 5 | $20 | ||
| LABTESTMET | Testing Method | Text | Char | $ | 128 | $512 | ||
| LABLOINC | LOINC Code | Text | Char | $ | 128 | $512 | ||
| LABSDTMNM | SDTM Name | Text | Char | $ | 255 | $1020 | ||
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
23R1 Version
Clinical Datasets
Each clinical dataset, and each Form (Adverse Events, Concomitant Medications, etc.), contains a set of Key Columns and a set of Clinical Data columns, which are detailed below.
Key Columns
Key Columns contain data to help identify which Form each row is referring to (ex: which Subject, Site, Cycle, or Event that particular form is located in).
The list of Key Columns is as follows:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | This column refers to study_label or study in the API. | |
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | 512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| VISMETHOD | Visit Method | Text | Char | $ | 100 | $400 | This column is only visible if Visit Method is enabled. | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| FORMSTATUS | Form Status | Text | Char | 100 | 400 | |||
| CREATEDT | Datetime Form Created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FIRSTSUBMITDT | Datetime Form First Submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | This field will only be populated for new studies created after 23R3. |
| LASTSUBMITDT | Datetime Form Last Submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| DLASTMOD | Datetime of last data change (UTC). This field is derived by taking the most recent datetime from all of the items' value_modified_date__v on the form. | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Datetime columns can be separated into two separate Date and Time columns. |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| IGGUID | Internal Vault ID (item groups) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| FORMILB | Intentionally Left Blank | Boolean | Char | $ | 5 | $20 | ||
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (Form Link ItemDef Name)_DEF | [Form Link Item Label] Definition | Text | Char | $ | 200 | $800 | If Item to Form Linking is enabled. Format of the cell value: Form Label that is linked to the item. The Form Sequence (#X) is included if the form is repeating. | |
| (Form Link ItemDef Name)_LINKEDFORMID | [Form Link Item Label] Linked Form ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled. | |
| (Form Link ItemDef Name)_LINKID | [Form Link Item Label] Link ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled. | |
| LINKEDTO 1 | Links to other forms | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| ITEMLINKEDTO 2 | Item Linked To | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| LINKEDITEM | Linked Item | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled. | |
| (ITEMNAME) | (Item Label) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_UTC | (Item Label)_UTC | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_USER | (Item Label)_User | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
|
1 This column displays in the following format: 2 This column displays in the following format: |
||||||||
*This column displays in the following format:
X Form(s): <Form Definition Label> [Form Definition Name] (#Y) – <Item Name 1> = <Item Value 1>, <Item Name 2> = <Item Value 2>, <Item Name 3> = <Item Value 3>
- X = total number of linked forms
- Y = number that is incremented
This format shows up to 3 items on the form, up to the maximum character limit.
Clinical Data
After the Key Columns, the system will insert Clinical Data columns, with each column representing an item on the Form.
Clinical Data Item Headers use the item names or external ID defined in Studio. Some items can be associated with more than one column, depending on their data type:
- Codelists are split into two columns:
- ITEMNAME: this column contains the codelist code
- ITEMNAME_D: this column contains the codelist decode or label
- Units are split into four columns:
- ITEMNAME: this column contains the value entered in the item
- ITEMNAME_U: this column contains the unit entered in the item
- ITEMNAME_TRANS: this column contains the “translated” item value, which is the value that was entered that has been converted to the standard unit
- ITEMNAME_TRANSU: this column contains the standard unit
- Datetimes are split into three columns:
- ITEMNAME: this column contains the datetime value entered (site’s timezone)
- ITEMNAME_UTC: this column contains the datetime value converted to UTC
- ITEMNAME_USER: this column contains the datetime value converted to the timezone of the user running the Study Data Extract
Unknown parts in dates and datetimes are represented by UN in ISO format:
- For a date: 2021-UN-UN
- For a datetime: 2021-UN-TUN:UN:UN.UNKZ
You can choose from the following Clinical Data options:
| Option | Description |
|---|---|
| Use Item External ID instead of Item Name for column headers | Replaces the column headers in the clinical datasets (which currently use the Item Name) with the Item External ID configured in Studio |
| Include Separate Date and Time columns for Datetime items | Creates two additional columns with the postfixes (Item)_DT and (Item)_TM for the Date and Time of the Datetime item |
| Include forms Intentionally Left Blank | Creates a column in the clinical datasets called FORMILB that indicates whether the form has been marked Intentionally Left Blank in clinical datasets (default behavior is to skip rows) |
| Exclude blank forms | Excludes forms whose status = "Blank" in the clinical datasets. Note that these forms will still appear in the SYS_FORM dataset |
Casebook Versions
All casebook versions are displayed in Study Data Extracts, so items that were deleted from the schedule in subsequent casebook versions will still appear in Clinical Datasets. This inclusion guarantees that all data is extracted, even if certain subjects were kept on a previous casebook version.
The Study Data Extract job first adds columns for all items that are present in Casebook Version 1 before adding columns for any items that may have been added in subsequent casebook versions to create the Study Data Extract file.
Lab Columns
Each form configured with Local Labs contains certain columns that are dynamically added after the LASTRUN column for lab items. Refer to the table below for a complete list of columns.
23R1 Version Lab Format Change: Clinical forms that are configured with Local Labs are formatted to decrease the number of columns outputted in SDE Version 23R1. In this version, Labs columns are shared across all analytes on the form instead of using multiple columns per analyte. See the SDE Versioning page for the list of Labs columns included in previous SDE versions.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | 128 | $512 | |||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | :vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| DLASTMOD | Datetime of last data change (UTC) | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| IGGUID | Internal Vault ID (Item Groups) | Text | Char | $ | 15 | $60 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| LBDTC | Collection Date Time | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBDTC_UTC | Collection Date Time_UTC | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBDTC_USER | Collection Date Time_USER | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBLOC | Lab Location* | Text | Char | $ | 128 | $512 | ||
| LBAGE | Age | Integer | Num | 14 | 8 | |||
| LBAGE_U | Age_U | Text | Char | 128 | $512 | |||
| LBAGE_TRANS | Age_TRANS | Integer | Num | 14 | 8 | |||
| LBAGE_TRANSU | Age_TRANSU | Text | Char | $ | 128 | $512 | ||
| LBTEST | Lab Test | Text | Char | $ | 128 | $512 | ||
| LABMODIFIER | Lab Modifier | Text | Char | $ | 128 | $512 | Visible for Studies using Global (Versionless) Labs if at least one analyte definition has Lab Modifiers configured. | |
| LABMODIFIER_D | Lab Modifier_D | Text | Char | $ | 256 | $1024 | Visible for Studies using Global (Versionless) Labs if at least one analyte definition has Lab Modifiers configured. | |
| LBORRES | Lab Result | Text, Float, or Integer | Char or Num | $ | 1500 or 14 | $6000 or 8 | Data type may be float or integer if all cells in that column have the same data type. Note that if the data type is float or integer, the length/SAS length may change to the default for numeric values. | |
| LBORRES_U_D | Lab Result Unit or Decode for Codelists and Units | Text | Char | $ | 1500 | $6000 | Visible for Unit, Number, Codelist, or Text analyte type. | |
| LBORRES_TRANS | Lab Result_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORRES_TRANSU | Lab Result_TRANSU | Text | Char | $ | 1500 | $6000 | ||
| LBORNRLO | Normal Range Lower Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRHI | Normal Range Upper Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRLOHI_U | Normal Range Lower and Upper Limit_U | Text | Char | $ | 1500 | $6000 | ||
| LBORNRLO_TRANS | Normal Range Lower Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRHI_TRANS | Normal Range Upper Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBORNRLOHI_TRANSU | Normal Range Lower and Upper Limit_TRANSU | Text | Char | $ | 1500 | $6000 | ||
| LBOVRDNRLO | Normal Range Override Lower Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDNRHI | Normal Range Override Upper Limit | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDNRLOHI_U | Normal Range Override Lower and Upper Limit_U | Text | Char | $ | 1500 | $6000 | ||
| LBOVRDNRLO_TRANS | Normal Range Override Lower Limit_TRANS | Float or Integer | Num | 14 | 8 | Data type may be integer if all cells in that column are integers. | ||
| LBOVRDRLOHI_TRANSU | Normal Range Override Lower and Upper Limit_TRANSU | Text | Char | $ | 1500 | $6000 | Data type may be integer if all cells in that column are integers. | |
| LBSTNRC | Normal Value | Text | Char | $ | 1500 | $6000 | For Codelist or Text-type Analytes. | |
| LBSTNRC_D | Normal Value_D | Text | Char | $ | 256 | $1024 | For Codelist-type Analytes. | |
| LBOVRDNRC | Normal Value Override | Text | Char | $ | 1500 | $6000 | For Codelist or Text-type Analytes. | |
| LBOVRDNRC_D | Normal Value Override_D | Text | Char | $ | 256 | $1024 | For Codelist-type Analytes. | |
| LBNRIND | Normal Range Indicator | Text | Char | $ | 1500 | $6000 | ||
| LBCLSIG | Clinical Significance | Text | Char | $ | 1500 | $6000 |
*This field refers to the Lab ID.
The LBDTC, LBLOC, and LBAGE columns are part of the Lab Header that is generated for each lab form. Each column related to a Lab Analyte with a “Unit” type has additional columns for the Unit (appended with _U), the Translated Value (appended with _TRANS), and the Translated Unit (appended with _TRANSU). For example, the Lab Result Unit for Sodium would display in the column header as LBORRES_Sodium_U.
Coding Data
If a form is set up for coding, meaning that a coding configuration has been defined in Studio, coding-related columns will be added after clinical data columns. If there are multiple verbatims set up in a form, the system will add a set of coding columns for each verbatim configured. If the same item in different item groups is configured for coding, the system will add “itemgroup.item” to each column header to indicate which set of columns belongs to which verbatim. Note that you need the View Code permission to view coding columns in the SDE.
List of coding columns for MedDRA:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| SOC | SOC | Text | Char | $ | 1500 | $6000 | |
| SOCID | SOC Code | Text | Char | $ | 1500 | $6000 | |
| HLGT | HLGT | Text | Char | $ | 1500 | $6000 | |
| HLGTID | HLGT Code | Text | Char | $ | 1500 | $6000 | |
| HLT | HLT | Text | Char | $ | 1500 | $6000 | |
| HLTID | HLT Code | Text | Char | $ | 1500 | $6000 | |
| PT | PT | Text | Char | $ | 1500 | $6000 | |
| PTID | PT Code | Text | Char | $ | 1500 | $6000 | |
| LLT | LLT | Text | Char | $ | 1500 | $6000 | |
| LLTID | LLT Code | Text | Char | $ | 1500 | $6000 | |
| PRIMPATH | Primary Path | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
List of coding columns for WHODrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| ATC1 | ATC1 | Text | Char | $ | 1500 | $6000 | |
| ATC1CD | ATC1 Code | Text | Char | $ | 1500 | $6000 | |
| ATC2 | ATC2 | Text | Char | $ | 1500 | $6000 | |
| ATC2CD | ATC2 Code | Text | Char | $ | 1500 | $6000 | |
| ATC3 | ATC3 | Text | Char | $ | 1500 | $6000 | |
| ATC3CD | ATC3 Code | Text | Char | $ | 1500 | $6000 | |
| ATC4 | ATC4 | Text | Char | $ | 1500 | $6000 | |
| ATC4CD | ATC4 Code | Text | Char | $ | 1500 | $6000 | |
| PREFNAME | Preferred Name | Text | Char | $ | 1500 | $6000 | |
| PREFCODE | Preferred Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| PREFBASE | Preferred Base Code | Text | Char | $ | 1500 | $6000 | |
| PREFLABEL | Preferred Base | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
List of coding columns for JDrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| GDRUGNAME | Generic Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT1 | Drug Code Category 1 | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT2 | Drug Code Category 2 | Text | Char | $ | 1500 | $6000 | |
| USECAT1 | Use Category 1 | Text | Char | $ | 1500 | $6000 | |
| USECAT2 | Use Category 2 | Text | Char | $ | 1500 | $6000 | |
| MANNAME | Manufacturer Name | Text | Char | $ | 1500 | $6000 | |
| MANCODE | Manufacturer Code | Text | Char | $ | 1500 | $6000 | |
| MAINTFLG | Maintenance Flag | Text | Char | $ | 1500 | $6000 | |
| MAINTDT | Maintenance Date | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
Definitions File
The Study Data Extract ZIP file contains a definition file, which is a listing of all columns across all datasets included in the extract.
List of columns included in the Definitions file:
| Column Header | Data |
|---|---|
| Dataset Name | Name of the dataset |
| Column | Name of the column |
| Type | Item type for clinical data items |
| SAS Type | SAS type of the column |
| SAS Informat | SAS informat applied |
| SAS Format | SAS format applied |
| Length | Length in characters |
| SAS Length | SAS length in bytes |
| Label | SAS Label of the column |
System Datasets
Along with clinical datasets, the Study Data Extract file contains several system datasets that contain operational data and metrics.
SYS_SITE
The SYS_SITE dataset lists all sites for the selected study.
List of SYS_SITE columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Study Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SITENAME | Study Site Name | Text | Char | $ | 128 | $512 | ||
| INVNAME | Principal Investigator | Text | Char | $ | 128 | $512 | ||
| CASEBDEF | Casebook Version | Integer | Num | 14 | 8 | |||
| STATUS | Site Status | Text | Char | $ | 100 | $400 | ||
| TIMEZONE | Timezone of the Site | Text | Char | $ | 100 | $400 | ||
| BULKCASEBOOKSIGNATURE | Bulk Casebook Signature | Boolean | Char | $ | 5 | $20.00 | ||
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_SUB
The SYS_SUB dataset lists all subjects for the selected study.
List of SYS_SUB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| CASEBDEF | Casebook Version | Integer | Num | 14 | 8 | |||
| STATUS | Status of the Subject/Casebook | Text | Char | $ | 100 | $400 | ||
| GUID | Internal Vault ID of the subject | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTMODDT | Subject Last Modified Datetime | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CNSNTDT | Initial Consent Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| SCRDDT | Screened date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| SCRFAILDT | Screen failed date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ENRDDT | Enrolled date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| RDMDDT | Randomized date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| STARTTRTDT | Started Treatment Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ENDTRTDT | End of treatment date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| WTHDRWNDT | Withdrawn date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| STARTFLLWUPDT | Started Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| LOSTFLLWUPDT | Lost to Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| CMPLTDT | End of study date | Date | Num | : vdate. | DATE9. | 14 | 8 |
SYS_EVT
The SYS_EVT dataset lists all events as well as event dates and status for the selected study.
List of SYS_EVT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | 512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9 | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| LASTMODDAT | Last modified date/time of the event date (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CASEBDEF | Casebook Version | Integer | Num | $ | 14 | 8 | ||
| STATUS | Status of the event/visit | Text | Char | $ | 100 | $400 | ||
| LASTREAS | Last change reason | Text | Char | $ | 255 | $1020 | ||
| WINSTAT | Scheduled Window Status | Text | Char | $ | 32 | $128 | ||
| DAYSOW | Days Outside Window | Integer | Num | 14 | 8 | |||
| EXPFORMS | Expected Number of Forms | Integer | Num | 14 | 8 | |||
| FORMEOD | Number of days past due when one or more forms is not yet complete | Integer | Num | 14 | 8 | |||
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_FORM
The SYS_FORM dataset lists all forms for the selected study, including forms Intentionally Left Blank as well as review statuses, freeze and lock statuses, and additional metrics.
List of SYS_FORM columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | 512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| STATUS | Form Status | Text | Char | $ | 100 | $400 | ||
| CREATEDT | Datetime form created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| SUBMITDT | Datetime form last submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Number of times form was submitted | Integer | Num | 14 | 8 | |||
| SDVREQ | SDV Required | Boolean | Char | $ | 5 | $20 | Not supported for SDV rollup V1 studies, will be blank | |
| SDVDT | Datetime considered SDV complete (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| SDVLAST | Datetime of last SDV modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TOSDV | Days from submit to SDV | Float | Num | 14 | 8 | |||
| DMRREQ | DMR Required | Boolean | Char | $ | 5 | $20 | Not supported for SDV rollup V1 studies, will be blank | |
| DMRDT | Datetime considered DMR complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| DMRLAST | Datetime of last DMR modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TODMR | Days from submit to DMR | Float | Num | 14 | 8 | |||
| FREEZEDT | Datetime frozen (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOFREEZE | Days from submit to freeze | Float | Num | 14 | 8 | |||
| LOCKDT | Datetime locked (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOLOCK | Days from submit to lock | Float | Num | 14 | 8 | |||
| SIGNDT | Datetime signed (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LSTSGNDT | Last Signature Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOSIGN | Days from submit to sign | Float | Num | 14 | 8 | |||
| EDT_SUBM | Days from event date (of form) to submit date | Float | Num | 14 | 8 | |||
| ILB | Intentionally Left Blank | Boolean | Char | $ | 5 | $20 | ||
| ILBREAS | Reason for Intentionally Left Blank | Text | Char | $ | 255 | $1020 | ||
| GUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_Q
The SYS_Q dataset lists all queries for the selected study, along with some query metrics. Only the first query message is listed in this dataset. The full list of query messages (first message, answers, etc.) is included in the SYS_QT dataset.
List of SYS_Q columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| ITEMGROUP | Item group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition Name | Text | Char | $ | 128 | 512 | ||
| IGSEQ | Item group sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | 128 | $512 | |||
| QUERYID | Query ID | Text | Char | $ | 128 | $512 | ||
| STATUS | Query status | Text | Char | $ | 100 | $400 | Includes Open, Answered, and Closed queries. | |
| RESTRICTED | Query Restricted | Boolean | Char | 5 | 20 | Visible if "Include Restricted Data" is selected in SDE Version 23R1. | ||
| MANUAL | Manual query | Boolean | Char | $ | 5 | $20 | ||
| RULEID | Rule name | Text | Char | $ | 128 | $512 | ||
| TRIGID | Trigger name | Text | Char | $ | 128 | $512 | ||
| QTEXT | Initial query text/message | Text | Char | $ | 500 | $2000 | ||
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created by | Text | Char | $ | 201 | $804 | ||
| LASTCLOSEDDT | Query Last Closed Date | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 | |
| QUERYTEAM | Query team | Text | Char | $ | 50 | $200 | ||
| QTFRESP | Time to first response (days) | Float | Num | 14 | 8 | Only populated when there's a First Response Date and the query has a status of "Answered." | ||
| QAGE | Query Age (days) | Float | Num | 14 | 8 | |||
| QCHGDATA | Whether the data changed after query creation (field query attached) | Boolean | Char | $ | 5 | $20 | ||
| QOTOCL | Query open to close (days) | Float | Num | 14 | 8 | |||
| GUID | Internal Vault ID of the query | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_QT
The SYS_QT dataset lists all query messages for the selected study.
You can link the content of this file with the SYS_Q dataset using the QUERYID column. There can be multiple SYS_QT records matching one SYS_Q record (i.e. a query in SYS_Q can have multiple query messages in SYS_QT).
List of SYS_QT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| QUERYID | Query ID | Text | Char | $ | 128 | $512 | ||
| STATUS | Query status | Text | Char | $ | 100 | $400 | Includes Open, Answered, Closed, and Reopened queries | |
| RESTRICTED | Query Restricted | Boolean | Char | 5 | 20 | Visible if "Include Restricted Data" is selected in SDE Version 23R1. | ||
| QTEXT | Initial query text/message | Text | Char | $ | 500 | $2000 | ||
| TEXTDT | Text/Message Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TEXTBY | Text/Message By | Text | Char | $ | 201 | $1804 | ||
| QUERYTEAM | Query team | Text | Char | $ | 50 | $200 | ||
| GUID | Internal Vault ID of the query message | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ILB
The SYS_ILB dataset lists all items that have been marked Intentionally Left Blank in the selected study.
List of SYS_ILB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition Name | Text | Char | 128 | 512 | |||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | 128 | 512 | |||
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | Visible if Local Labs is enabled | |
| ILBREAS | Reason for intentionally left blank | Text | Char | $ | 255 | $1020 | ||
| GUID | Internal Vault ID of the item/field | Text | Char | $ | 100 | $400 | For HVO objects (item2__v), the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LINKS
The SYS_LINKS dataset lists all forms that belong to a form link in the selected study. Forms that are linked together will share the same link ID, which will display in the GUID column. The form unique identifier (FGUID) can then be used to identify a specific form and access its data.
List of SYS_LINKS columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Description |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form external ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | Only visible if Form Linking is enabled. | |
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | Only visible if Form Linking is enabled. | |
| ITEMEID | Item External ID | Text | Char | 128 | $512 | Only visible if Form Linking is enabled. | ||
| FORMCREATEDDT | Form Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LINKCREATEDDT | Link Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created by | Text | Char | $ | 201 | $804 | ||
| FGUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| GUID | Internal Link ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASM
The SYS_ASM dataset lists the following information about assessments, if assessments are configured for a Study.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| ASMNAME | Assessment Name | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| ASMEID | Assessment External ID | Text | Char | $ | 128 | $512 | ||
| ASMTYPE | Assessment Type | Text | Char | $ | 128 | $512 | ||
| REASSESSMENT | Reassessment | Boolean | Char | $ | 5 | 20 | ||
| SOURCEF | Source Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| STATUS | Status of Assessment | Text | Char | $ | 100 | $400 | ||
| SOURCEFRESTRICTED | Source Form Restricted | Boolean | Char | $ | 5 | $20 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| COMPDT | Completed Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Submit Count | Integer | Num | 14 | 8 | |||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| GUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| FGUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASMR
The SYS_ASMR dataset lists questions and answers for all assessments in a Study, if assessments are configured.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| ASMNAME | Assessment Name | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| ASMEID | Assessment External ID | Text | Char | $ | 128 | $512 | ||
| QUESTEXT | Question Text | Text | Char | $ | 128 | $512 | ||
| QUESTEXTDEF | Question Text Definition | Text | Char | $ | 128 | $512 | ||
| QUESANS | Question Answer | Text | Char | $ | 1500 | $6000 | ||
| SOURCEFRESTRICTED | Source Form Restricted | Boolean | Char | $ | 5 | $20 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| AGUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_PD
The SYS_PD dataset lists the following Protocol Deviations information, if Protocol Deviations is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| PDID | Protocol Deviation Identifier | Text | Char | $ | 128 | $512 | ||
| PDSUM | Protocol Deviation Summary | Text | Char | $ | 250 | $1000 | ||
| PDDAT | Date of Deviation | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDDATID | Date Identified | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDCAT | Category | Text | Char | $ | 128 | $512 | ||
| PDCATLABEL | Category Label | Text | Char | $ | 128 | $512 | ||
| PDSUBCAT | Subcategory | Text | Char | $ | 128 | $512 | ||
| PDSUBCATLABEL | Subcategory Label | Text | Char | $ | 128 | $512 | ||
| PDSEV | Severity | Text | Char | $ | 128 | $512 | ||
| PDSEVLABEL | Severity Label | Text | Char | $ | 128 | $512 | ||
| PDDESC | Description | Text | Char | $ | 500 | $2000 | ||
| PDSTATUS | Protocol Deviation Status | Text | Char | $ | 100 | $400 | ||
| PDRES | Protocol Deviation Resolution | Text | Char | $ | 500 | $2000 | ||
| PDRULE | Protocol Deviation Rule | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | 128 | $512 | |||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| USERMODDT | User Modified Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| USERMODB | User Modified By | Text | Char | $ | 201 | $804 | ||
| INACBYSYS | Inactivated by System | Boolean | Char | $ | 5 | $20 | ||
| LASTINACDT | Last Inactivated Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID of Form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| PDGUID | Internal Vault ID of Protocol Deviation | Text | Char | $ | 15 | $60 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_RAND
The SYS_RAND dataset lists the following Randomization information, if Randomization is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITE | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| RANDSTATUS | Randomization Status | Text | Char | $ | 100 | $400 | ||
| RANDID | Randomization ID | Text | Char | $ | 128 | $512 | ||
| TREATMENTNAME* | Treatment Name | Text | Char | $ | 128 | $512 | ||
| TREATMENTLABEL* | Treatment Label | Text | Char | $ | 1500 | $6000 | ||
| TREATMENTARM* | Treatment Arm | Text | Char | $ | 128 | $512 | Visible if "Include Randomization Treatment" is selected in SDE Version 22R1 or later | |
| RANDSTRATA | Strata Group | Text | Char | $ | 128 | $512 | ||
| RANDBY | Randomized By | Text | Char | $ | 201 | $804 | ||
| RANDDAT | Randomized Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| RANDFILE | Randomization File Label | Text | Char | $ | 128 | $512 | ||
| RANDFILEDAT | Randomization File Upload Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
*These columns are only available for unmasked studies with Randomization enabled and users with the View Unmasked Data and View Randomization Enrollment permissions. To include these columns, check the Include Randomization Treatment box in the New Job dialog. Note that you can’t download SDE files from users with the View Randomization Enrollment permission if the Include Randomization Treatment checkbox is not visible to you in the SDE job dialog.
SYS_LABRANGES
The SYS_LABRANGES dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | |
| LABLOC | Lab Location | Text | Char | $ | 128 | $512 | |
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | |
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 128 | $512 | |
| LABREFRSTATUS | Lab Reference Range Status | Text | Char | $ | 100 | $400 | |
| LABTESTCODE | Test Code | Text | Char | $ | 128 | $512 | |
| LABSEX | Sex | Text | Char | $ | 128 | $512 | |
| LABLOWERAGE | Lower Age | Integer | Num | 14 | 8 | ||
| LABUPPERAGE | Upper Age | Integer | Num | 14 | 8 | ||
| LABAGEUNIT | Age Unit | Text | Char | $ | 128 | $512 | |
| LABFEMCYCLE | Female Cycle | Text | Char | $ | 128 | $512 | |
| LABLNORMAL | Lower Normal | Float | Num | 14 | 8 | ||
| LABUNORMAL | Upper Normal | Float | Num | 14 | 8 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 128 | $512 | |
| LABMEASUNITLABEL | Measurement Unit Label | Text | Char | $ | 128 | $512 | |
| LABCODENORM | Codelist Normal | Text | Char | $ | 128 | $512 | |
| LABTEXTNORM | Text Normal | Text | Char | $ | 3000 | $12000 | |
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | $20 | |
| LABFROMDT | Effective From Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABTODT | Effective To Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABDESCR | Description | Text | Char | $ | 500 | $2000 | |
| LABSPECTYPE | Specimen Type | Text | Char | $ | 128 | $512 | |
| LABTESTMET | Testing Method | Text | Char | $ | 128 | $512 | |
| CREATB | Created By | Text | Char | $ | 201 | $804 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LABLOC
The SYS_LABLOC dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | ||
| LABLOC | Lab Location | Text | Char | $ | 128 | $512 | ||
| LABLOCSTATUS | Lab Location Status | Text | Char | $ | 100 | $400 | ||
| LABAPPROVED | Approved Lab Location | Text | Char | $ | 128 | $512 | ||
| LABADDRESS | Lab Address | Text | Char | $ | 500 | $2000 | ||
| LABCOUNTRY | Lab Country | Text | Char | $ | 128 | $512 | ||
| LABCONTACT | Lab Contact Name | Text | Char | $ | 128 | $512 | ||
| LABCONTITLE | Lab Contact Title | Text | Char | $ | 128 | $512 | ||
| LABTEL | Lab Telephone | Text | Char | $ | 40 | $160 | ||
| LABFAX | Lab Fax | Text | Char | $ | 40 | $160 | ||
| LABPRIMEMAIL | Lab Primary Email | Text | Char | $ | 80 | $320 | ||
| LABSECMAIL | Lab Secondary Email | Text | Char | $ | 80 | $320 | ||
| LABSTATUS | Lab Status | Text | Char | $ | 100 | $400 | ||
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ANALYTES
The SYS_ANALYTES dataset lists the following Labs analyte information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | ||
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 128 | $512 | ||
| LABDESCR | Description | Text | Char | $ | 500 | $2000 | ||
| LABDATATYPE | Data Type | Text | Char | $ | 100 | $400 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 128 | $512 | ||
| LABCODELIST | Codelist | Text | Char | $ | 128 | $512 | ||
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | $20 | ||
| LABSPECTYPE | Specimen Type | Text | Char | $ | 128 | $512 | ||
| LABLEN | Length | Integer | Num | 14 | 8 | |||
| LABPREC | Precision | Integer | Num | 14 | 8 | |||
| LABSYSMANAGED | System Managed | Boolean | Char | $ | 5 | $20 | ||
| LABTESTMET | Testing Method | Text | Char | $ | 128 | $512 | ||
| LABLOINC | LOINC Code | Text | Char | $ | 128 | $512 | ||
| LABSDTMNM | SDTM Name | Text | Char | $ | 255 | $1020 | ||
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
22R3 Version
Clinical Datasets
Each clinical dataset, and each Form (Adverse Events, Concomitant Medications, etc.), contains a set of Key Columns and a set of Clinical Data columns, which are detailed below.
Key Columns
Key Columns contain data to help identify which Form each row is referring to (ex: which Subject, Site, Cycle, or Event that particular form is located in).
The list of Key Columns is as follows:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| DLASTMOD | Datetime of last data change (UTC). This field is derived by taking the most recent datetime from all of the items' value_modified_date__v on the form. | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Datetime columns can be separated into two separate Date and Time columns. |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| IGGUID | Internal Vault ID (item groups) | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| FORMILB | Intentionally Left Blank | Boolean | Char | $ | 5 | $20 | ||
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (Form Link ItemDef Name)_DEF | [Form Link Item Label] Definition | Text | Char | $ | 200 | $800 | If Item to Form Linking is enabled. Format of the cell value: Form Label that is linked to the item. The Form Sequence (#X) is included if the form is repeating. | |
| (Form Link ItemDef Name)_LINKEDFORMID | [Form Link Item Label] Linked Form ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled | |
| (Form Link ItemDef Name)_LINKID | [Form Link Item Label] Link ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled | |
| LINKEDTO* | Links to other forms | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled | |
| ITEMLINKEDTO | Item Linked To | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled | |
| LINKEDITEM | Linked Item | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled | |
| (ITEMNAME) | (Item Label) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_UTC | (Item Label)_UTC | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_USER | (Item Label)_User | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
*This column displays in the following format:
X Form(s): <Form Definition Label> [Form Definition Name] (#Y) – <Item Name 1> = <Item Value 1>, <Item Name 2> = <Item Value 2>, <Item Name 3> = <Item Value 3>
- X = total number of linked forms
- Y = number that is incremented
This format shows up to 3 items on the form, up to the maximum character limit.
Lab Columns
Each form configured with Local Labs contains certain columns that are dynamically added after the LASTRUN column for lab items. Refer to the table below for a complete list of columns.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LBDTC | Collection Date Time | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBLOC | Lab Location* | Text | Char | $ | 128 | $512 | ||
| LBAGE | Age | Integer | Num | 14 | 8 | |||
| LABMODIFIER_(ANALYTE) | Lab Modifier | Text | Char | $ | 128 | $512 | Visible for Studies using Global (Versionless) Labs with a Lab Modifier configured for the analyte and running the 22R3 SDE version. An additional column will be visible for the decode denoted with _D | |
| LBORRES_(ANALYTE) | Lab Result | Float | Num | 14 | 8 | |||
| LBORNRLO_(ANALYTE) | Normal Range Lower Limit | Float | Num | 14 | 8 | For Unit or Number-type Analytes | ||
| LBORNRHI_(ANALYTE) | Normal Range Upper Limit | Float | Num | 14 | 8 | For Unit or Number-type Analytes | ||
| LBOVRDNRLO_(ANALYTE) | Normal Range Override Lower Limit | Float | Num | 14 | 8 | For Unit or Number-type Analytes | ||
| LBOVRDNRHI_(ANALYTE) | Normal Range Override Upper Limit | Float | Num | 14 | 8 | For Unit or Number-type Analytes | ||
| LBSTNRC_(ANALYTE) | Normal Value | Text | Char | $ | item_def__v.length__v | item_def__v.length__v * 4 | For Codelist or Text-type Analytes | |
| LBSTNRC_(ANALYTE)_D | Normal Value_D | Text | Char | $ | 256 | $1024 | For Codelist-type Analytes | |
| LBOVRDNRC_(ANALYTE) | Normal Value Override | Text | Char | $ | item_def__v.length__v | item_def__v.length__v * 4 | For Codelist or Text-type Analytes | |
| LBOVRDNRC_(ANALYTE)_D | Normal Value Override_D | Text | Char | $ | 256 | $1024 | For Codelist-type Analytes | |
| LBNRIND_(ANALYTE) | Normal Range Indicator | Text | Char | $ | 1500 | $6000 | ||
| LBCLSIG_(ANALYTE) | Clinical Significance | Text | Char | $ | 1500 | $6000 |
*This field refers to the Lab ID.
The LBDTC, LBLOC, and LBAGE columns are part of the Lab Header that is generated for each lab form. Each column related to a Lab Analyte with a “Unit” type has additional columns for the Unit (appended with _U), the Translated Value (appended with _TRANS), and the Translated Unit (appended with _TRANSU). For example, the Lab Result Unit for Sodium would display in the column header as LBORRES_Sodium_U.
Coding Data
If a form is set up for coding, meaning that a coding configuration has been defined in Studio, coding-related columns will be added after clinical data columns. If there are multiple verbatims set up in a form, the system will add a set of coding columns for each verbatim configured. If the same item in different item groups is configured for coding, the system will add “itemgroup.item” to each column header to indicate which set of columns belongs to which verbatim. Note that you need the View Code permission to view coding columns in the SDE.
List of coding columns for MedDRA:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| SOC | SOC | Text | Char | $ | 1500 | $6000 | |
| SOCID | SOC Code | Text | Char | $ | 1500 | $6000 | |
| HLGT | HLGT | Text | Char | $ | 1500 | $6000 | |
| HLGTID | HLGT Code | Text | Char | $ | 1500 | $6000 | |
| HLT | HLT | Text | Char | $ | 1500 | $6000 | |
| HLTID | HLT Code | Text | Char | $ | 1500 | $6000 | |
| PT | PT | Text | Char | $ | 1500 | $6000 | |
| PTID | PT Code | Text | Char | $ | 1500 | $6000 | |
| LLT | LLT | Text | Char | $ | 1500 | $6000 | |
| LLTID | LLT Code | Text | Char | $ | 1500 | $6000 | |
| PRIMPATH | Primary Path | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
List of coding columns for WHODrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| ATC1 | ATC1 | Text | Char | $ | 1500 | $6000 | |
| ATC1CD | ATC1 Code | Text | Char | $ | 1500 | $6000 | |
| ATC2 | ATC2 | Text | Char | $ | 1500 | $6000 | |
| ATC2CD | ATC2 Code | Text | Char | $ | 1500 | $6000 | |
| ATC3 | ATC3 | Text | Char | $ | 1500 | $6000 | |
| ATC3CD | ATC3 Code | Text | Char | $ | 1500 | $6000 | |
| ATC4 | ATC4 | Text | Char | $ | 1500 | $6000 | |
| ATC4CD | ATC4 Code | Text | Char | $ | 1500 | $6000 | |
| PREFNAME | Preferred Name | Text | Char | $ | 1500 | $6000 | |
| PREFCODE | Preferred Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| PREFBASE | Preferred Base Code | Text | Char | $ | 1500 | $6000 | |
| PREFLABEL | Preferred Base | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
List of coding columns for JDrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| GDRUGNAME | Generic Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT1 | Drug Code Category 1 | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT2 | Drug Code Category 2 | Text | Char | $ | 1500 | $6000 | |
| USECAT1 | Use Category 1 | Text | Char | $ | 1500 | $6000 | |
| USECAT2 | Use Category 2 | Text | Char | $ | 1500 | $6000 | |
| MANNAME | Manufacturer Name | Text | Char | $ | 1500 | $6000 | |
| MANCODE | Manufacturer Code | Text | Char | $ | 1500 | $6000 | |
| MAINTFLG | Maintenance Flag | Text | Char | $ | 1500 | $6000 | |
| MAINTDT | Maintenance Date | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
Definitions File
The Study Data Extract ZIP file contains a definition file, which is a listing of all columns across all datasets included in the extract.
List of columns included in the Definitions file:
| Column Header | Data |
|---|---|
| Dataset Name | Name of the dataset |
| Column | Name of the column |
| Type | Item type for clinical data items |
| SAS Type | SAS type of the column |
| SAS Informat | SAS informat applied |
| SAS Format | SAS format applied |
| Length | Length in characters |
| SAS Length | SAS length in bytes |
| Label | SAS Label of the column |
System Datasets
Along with clinical datasets, the Study Data Extract file contains several system datasets that contain operational data and metrics.
SYS_SITE
The SYS_SITE dataset lists all sites for the selected study.
List of SYS_SITE columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Study Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SITENAME | Study Site Name | Text | Char | $ | 128 | $512 | ||
| INVNAME | Principal Investigator | Text | Char | $ | 128 | $512 | ||
| CASEBDEF | Casebook Version | Integer | Num | 14 | 8 | |||
| STATUS | Site Status | Text | Char | $ | 100 | $400 | ||
| TIMEZONE | Timezone of the Site | Text | Char | $ | 100 | $400 | ||
| BULKCASEBOOKSIGNATURE | Bulk Casebook Signature | Boolean | Char | $ | 5 | $20.00 | ||
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_SUB
The SYS_SUB dataset lists all subjects for the selected study.
List of SYS_SUB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| CASEBDEF | Casebook Version | Integer | Num | 14 | 8 | |||
| STATUS | Status of the Subject/Casebook | Text | Char | $ | 100 | $400 | ||
| GUID | Internal Vault ID of the subject | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CNSNTDT | Initial Consent Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| SCRDDT | Screened date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| SCRFAILDT | Screen failed date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ENRDDT | Enrolled date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| RDMDDT | Randomized date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| STARTTRTDT | Started Treatment Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ENDTRTDT | End of treatment date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| WTHDRWNDT | Withdrawn date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| STARTFLLWUPDT | Started Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| LOSTFLLWUPDT | Lost to Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| CMPLTDT | End of study date | Date | Num | : vdate. | DATE9. | 14 | 8 |
SYS_EVT
The SYS_EVT dataset lists all events as well as event dates and status for the selected study.
List of SYS_EVT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9 | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| LASTMODDAT | Last modified date/time of the event date (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CASEBDEF | Casebook Version | Integer | Num | $ | 14 | 8 | ||
| STATUS | Status of the event/visit | Text | Char | $ | 100 | $400 | ||
| LASTREAS | Last change reason | Text | Char | $ | 255 | $1020 | ||
| WINSTAT | Scheduled Window Status | Text | Char | $ | 32 | $128 | ||
| DAYSOW | Days Outside Window | Integer | Num | 14 | 8 | |||
| EXPFORMS | Expected Number of Forms | Integer | Num | 14 | 8 | |||
| FORMEOD | Number of days past due when one or more forms is not yet complete | Integer | Num | 14 | 8 | |||
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_FORM
The SYS_FORM dataset lists all forms for the selected study, including forms Intentionally Left Blank as well as review statuses, freeze and lock statuses, and additional metrics.
List of SYS_FORM columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| EVENTDT | Event date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| STATUS | Form Status | Text | Char | $ | 100 | $400 | ||
| CREATEDT | Datetime form created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| SUBMITDT | Datetime form last submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Number of times form was submitted | Integer | Num | 14 | 8 | |||
| SDVREQ | SDV Required | Boolean | Char | $ | 5 | $20 | Not supported for SDV rollup V1 studies, will be blank | |
| SDVDT | Datetime considered SDV complete (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| SDVLAST | Datetime of last SDV modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TOSDV | Days from submit to SDV | Float | Num | 14 | 8 | |||
| DMRREQ | DMR Required | Boolean | Char | $ | 5 | $20 | Not supported for SDV rollup V1 studies, will be blank | |
| DMRDT | Datetime considered DMR complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| DMRLAST | Datetime of last DMR modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TODMR | Days from submit to DMR | Float | Num | 14 | 8 | |||
| FREEZEDT | Datetime frozen (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOFREEZE | Days from submit to freeze | Float | Num | 14 | 8 | |||
| LOCKDT | Datetime locked (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOLOCK | Days from submit to lock | Float | Num | 14 | 8 | |||
| SIGNDT | Datetime signed (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LSTSGNDT | Last Signature Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOSIGN | Days from submit to sign | Float | Num | 14 | 8 | |||
| EDT_SUBM | Days from event date (of form) to submit date | Float | Num | 14 | 8 | |||
| ILB | Intentionally Left Blank | Boolean | Char | $ | 5 | $20 | ||
| ILBREAS | Reason for Intentionally Left Blank | Text | Char | $ | 255 | $1020 | ||
| GUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_Q
The SYS_Q dataset lists all queries for the selected study, along with some query metrics. Only the first query message is listed in this dataset. The full list of query messages (first message, answers, etc.) is included in the SYS_QT dataset.
List of SYS_Q columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| ITEMGROUP | Item group | Text | Char | $ | 500 | $2000 | ||
| IGSEQ | Item group sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| QUERYID | Query ID | Text | Char | $ | 128 | $512 | ||
| STATUS | Query status | Text | Char | $ | 100 | $400 | Includes Open, Answered, and Closed queries | |
| MANUAL | Manual query | Boolean | Char | $ | 5 | $20 | ||
| RULEID | Rule name | Text | Char | $ | 128 | $512 | ||
| TRIGID | Trigger name | Text | Char | $ | 128 | $512 | ||
| QTEXT | Initial query text/message | Text | Char | $ | 500 | $2000 | ||
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created by | Text | Char | $ | 201 | $804 | ||
| QUERYTEAM | Query team | Text | Char | $ | 50 | $200 | ||
| QTFRESP | Time to first response (days) | Float | Num | 14 | 8 | Only populated when there's a First Response Date and the query has a status of "Answered" | ||
| QAGE | Query Age (days) | Float | Num | 14 | 8 | |||
| QCHGDATA | Whether the data changed after query creation (field query attached) | Boolean | Char | $ | 5 | $20 | ||
| QOTOCL | Query open to close (days) | Float | Num | 14 | 8 | |||
| GUID | Internal Vault ID of the query | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_QT
The SYS_QT dataset lists all query messages for the selected study.
You can link the content of this file with the SYS_Q dataset using the QUERYID column. There can be multiple SYS_QT records matching one SYS_Q record (i.e. a query in SYS_Q can have multiple query messages in SYS_QT).
List of SYS_QT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| QUERYID | Query ID | Text | Char | $ | 128 | $512 | ||
| STATUS | Query status | Text | Char | $ | 100 | $400 | Includes Open, Answered, Closed, and Reopened queries | |
| QTEXT | Initial query text/message | Text | Char | $ | 500 | $2000 | ||
| TEXTDT | Text/Message Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TEXTBY | Text/Message By | Text | Char | $ | 201 | $1804 | ||
| QUERYTEAM | Query team | Text | Char | $ | 50 | $200 | ||
| GUID | Internal Vault ID of the query message | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ILB
The SYS_ILB dataset lists all items that have been marked Intentionally Left Blank in the selected study.
List of SYS_ILB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | Visible if Local Labs is enabled | |
| DATASETNAME | Dataset name | Text | Char | $ | 128 | $512 | ||
| ILBREAS | Reason for intentionally left blank | Text | Char | $ | 255 | $1020 | ||
| GUID | Internal Vault ID of the item/field | Text | Char | $ | 100 | $400 | For HVO objects (item2__v), the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LINKS
The SYS_LINKS dataset lists all forms that belong to a form link in the selected study. Forms that are linked together will share the same link ID, which will display in the GUID column. The form unique identifier (FGUID) can then be used to identify a specific form and access its data.
List of SYS_LINKS columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Description |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External Id | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form external ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created by | Text | Char | $ | 201 | $804 | ||
| FGUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| GUID | Internal Link ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASM
The SYS_ASM dataset lists the following information about assessments, if assessments are configured for a Study.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Description |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| ASMNAME | Assessment Name | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| ASMTYPE | Assessment Type | Text | Char | $ | 128 | $512 | ||
| SOURCEF | Source Form | Text | Char | $ | 128 | $512 | ||
| STATUS | Status of Assessment | Text | Char | $ | 100 | $400 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| COMPDT | Completed Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Submit Count | Integer | Num | 14 | 8 | |||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| GUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| FGUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASMR
The SYS_ASMR dataset lists questions and answers for all assessments in a Study, if assessments are configured.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| QUESTEXT | Question Text | Text | Char | $ | 128 | $512 | ||
| QUESANS | Question Answer | Text | Char | $ | 1500 | $6000 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| AGUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_PD
The SYS_PD dataset lists the following Protocol Deviations information, if Protocol Deviations is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| PDID | Protocol Deviation Identifier | Text | Char | $ | 128 | $512 | ||
| PDSUM | Protocol Deviation Summary | Text | Char | $ | 250 | $1000 | ||
| PDDAT | Date of Deviation | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDDATID | Date Identified | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDCAT | Category | Text | Char | $ | 128 | $512 | ||
| PDCATLABEL | Category Label | Text | Char | $ | 128 | $512 | ||
| PDSUBCAT | Subcategory | Text | Char | $ | 128 | $512 | ||
| PDSUBCATLABEL | Subcategory Label | Text | Char | $ | 128 | $512 | ||
| PDSEV | Severity | Text | Char | $ | 128 | $512 | ||
| PDSEVLABEL | Severity Label | Text | Char | $ | 128 | $512 | ||
| PDDESC | Description | Text | Char | $ | 500 | $2000 | ||
| PDSTATUS | Protocol Deviation Status | Text | Char | $ | 100 | $400 | ||
| PDRES | Protocol Deviation Resolution | Text | Char | $ | 500 | $2000 | ||
| PDRULE | Protocol Deviation Rule | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| USERMODDT | User Modified Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| USERMODB | User Modified By | Text | Char | $ | 201 | $804 | ||
| INACBYSYS | Inactivated by System | Boolean | Char | $ | 5 | $20 | ||
| LASTINACDT | Last Inactivated Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID of Form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| PDGUID | Internal Vault ID of Protocol Deviation | Text | Char | $ | 15 | $60 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_RAND
The SYS_RAND dataset lists the following Randomization information, if Randomization is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITE | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| RANDSTATUS | Randomization Status | Text | Char | $ | 100 | $400 | ||
| RANDID | Randomization ID | Text | Char | $ | 128 | $512 | ||
| TREATMENTNAME* | Treatment Name | Text | Char | $ | 128 | $512 | ||
| TREATMENTLABEL* | Treatment Label | Text | Char | $ | 1500 | $6000 | ||
| TREATMENTARM* | Treatment Arm | Text | Char | $ | 128 | $512 | Visible if "Include Randomization Treatment" is selected in SDE Version 22R1 or later | |
| RANDSTRATA | Strata Group | Text | Char | $ | 128 | $512 | ||
| RANDBY | Randomized By | Text | Char | $ | 201 | $804 | ||
| RANDDAT | Randomized Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| RANDFILE | Randomization File Label | Text | Char | $ | 128 | $512 | ||
| RANDFILEDAT | Randomization File Upload Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
*These columns are only available for unmasked studies with Randomization enabled and users with the View Unmasked Data and View Randomization Enrollment permissions. To include these columns, check the Include Randomization Treatment box in the New Job dialog. Note that you can’t download SDE files from users with the View Randomization Enrollment permission if the Include Randomization Treatment checkbox is not visible to you in the SDE job dialog.
SYS_LABRANGES
The SYS_LABRANGES dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | |
| LABLOC | Lab Location | Text | Char | $ | 128 | $512 | |
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | |
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 128 | $512 | |
| LABREFRSTATUS | Lab Reference Range Status | Text | Char | $ | 100 | $400 | |
| LABTESTCODE | Test Code | Text | Char | $ | 128 | $512 | |
| LABSEX | Sex | Text | Char | $ | 128 | $512 | |
| LABLOWERAGE | Lower Age | Integer | Num | 14 | 8 | ||
| LABUPPERAGE | Upper Age | Integer | Num | 14 | 8 | ||
| LABAGEUNIT | Age Unit | Text | Char | $ | 128 | $512 | |
| LABFEMCYCLE | Female Cycle | Text | Char | $ | 128 | $512 | |
| LABLNORMAL | Lower Normal | Float | Num | 14 | 8 | ||
| LABUNORMAL | Upper Normal | Float | Num | 14 | 8 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 128 | $512 | |
| LABMEASUNITLABEL | Measurement Unit Label | Text | Char | $ | 128 | $512 | |
| LABCODENORM | Codelist Normal | Text | Char | $ | 128 | $512 | |
| LABTEXTNORM | Text Normal | Text | Char | $ | 3000 | $12000 | |
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | $20 | |
| LABFROMDT | Effective From Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABTODT | Effective To Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABDESCR | Description | Text | Char | $ | 500 | $2000 | |
| LABSPECTYPE | Specimen Type | Text | Char | $ | 128 | $512 | |
| LABTESTMET | Testing Method | Text | Char | $ | 128 | $512 | |
| CREATB | Created By | Text | Char | $ | 201 | $804 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LABLOC
The SYS_LABLOC dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | ||
| LABLOC | Lab Location | Text | Char | $ | 128 | $512 | ||
| LABLOCSTATUS | Lab Location Status | Text | Char | $ | 100 | $400 | ||
| LABAPPROVED | Approved Lab Location | Text | Char | $ | 128 | $512 | ||
| LABADDRESS | Lab Address | Text | Char | $ | 500 | $2000 | ||
| LABCOUNTRY | Lab Country | Text | Char | $ | 128 | $512 | ||
| LABCONTACT | Lab Contact Name | Text | Char | $ | 128 | $512 | ||
| LABCONTITLE | Lab Contact Title | Text | Char | $ | 128 | $512 | ||
| LABTEL | Lab Telephone | Text | Char | $ | 40 | $160 | ||
| LABFAX | Lab Fax | Text | Char | $ | 40 | $160 | ||
| LABPRIMEMAIL | Lab Primary Email | Text | Char | $ | 80 | $320 | ||
| LABSECMAIL | Lab Secondary Email | Text | Char | $ | 80 | $320 | ||
| LABSTATUS | Lab Status | Text | Char | $ | 100 | $400 | ||
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ANALYTES
The SYS_ANALYTES dataset lists the following Labs analyte information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | ||
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 128 | $512 | ||
| LABDESCR | Description | Text | Char | $ | 500 | $2000 | ||
| LABDATATYPE | Data Type | Text | Char | $ | 100 | $400 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 128 | $512 | ||
| LABCODELIST | Codelist | Text | Char | $ | 128 | $512 | ||
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | $20 | ||
| LABSPECTYPE | Specimen Type | Text | Char | $ | 128 | $512 | ||
| LABLEN | Length | Integer | Num | 14 | 8 | |||
| LABPREC | Precision | Integer | Num | 14 | 8 | |||
| LABSYSMANAGED | System Managed | Boolean | Char | $ | 5 | $20 | ||
| LABTESTMET | Testing Method | Text | Char | $ | 128 | $512 | ||
| LABLOINC | LOINC Code | Text | Char | $ | 128 | $512 | ||
| LABSDTMNM | SDTM Name | Text | Char | $ | 255 | $1020 | ||
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
22R2 Version
SAS Format (for versions before 23R1):
Duplicate Column Headers CSV: Duplicate column headers in CSV files aren’t appended with ‘_X’ (X being the number that can be incremented) as they are in SAS files. Because CSV files are used to generate SAS files, appended column headers are shown in the Study Definitions file even when the CSV column isn’t appended.
Clinical Datasets
Each clinical dataset, and each Form (Adverse Events, Concomitant Medications, etc.), contains a set of Key Columns and a set of Clinical Data columns, which are detailed below.
Key Columns
Key Columns contain data to help identify which Form each row is referring to (ex: which Subject, Site, Cycle, or Event that particular form is located in).
The list of Key Columns is as follows:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | ||
| COUNTRY | Country | Text | Char | $ | 100 | $100 | ||
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | ||
| SUBJID | Subject | Text | Char | $ | 100 | $100 | ||
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | ||
| EVENT | Event | Text | Char | $ | 200 | $200 | ||
| EVENTEID | Event External ID | Text | Char | $ | 200 | $200 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 200 | $200 | ||
| FORMEID | Form External ID | Text | Char | $ | 100 | $100 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| DLASTMOD* | Datetime of last data change (UTC). This field is derived by taking the most recent datetime from all of the items' value_modified_date__v on the form. | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 200 | $200 | ||
| IGGUID | Internal Vault ID (item groups) | Text | Char | $ | 1000 | $1000 | ||
| FORMILB | Intentionally Left Blank | Boolean | Char | $ | 1 | $1 | ||
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (Form Link ItemDef Name)_DEF | [Form Link Item Label] Definition | Text | Char | $ | 200 | $800 | If Item to Form Linking is enabled. Format of the cell value: Form Label that is linked to the item. The Form Sequence (#X) is included if the form is repeating. | |
| (Form Link ItemDef Name)_LINKEDFORMID | [Form Link Item Label] Linked Form ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled | |
| (Form Link ItemDef Name)_LINKID | [Form Link Item Label] Link ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled | |
| LINKEDTO | Links to other forms | Text | Char | $ | 1500 | $1500 | If Item to Form Linking is enabled | |
| ITEMLINKEDTO | Item Linked To | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled | |
| LINKEDITEM | Linked Item | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled | |
| (ITEMNAME) | (Item Label) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_UTC | (Item Label)_UTC | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (ITEMNAME)_USER | (Item Label)_USER | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
*Datetime columns can be separated into two separate Date and Time columns.
Casebook Versions
All casebook versions are displayed in Study Data Extracts, so items that were deleted from the schedule in subsequent casebook versions will still appear in Clinical Datasets. This inclusion guarantees that all data is extracted, even if certain subjects were kept on a previous casebook version.
The Study Data Extract job first adds columns for all items that are present in Casebook Version 1 before adding columns for any items that may have been added in subsequent casebook versions to create the Study Data Extract file.
Lab Columns
Each form configured with Local Labs contains certain columns that are dynamically added after the LASTRUN column for lab items. Refer to the table below for a complete list of columns.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LBDTC | Collection Date Time | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBLOC | Lab Location* | Text | Char | $ | 1500 | $1500.00 | ||
| LBAGE | Age | Integer | Num | 14 | 8 | |||
| LBORRES_(ANALYTE) | Lab Result | Float | Num | 14 | 8 | |||
| LBORNRLO_(ANALYTE) | Normal Range Lower Limit | Float | Num | 14 | 8 | For Unit or Number-type Analytes | ||
| LBORNRHI_(ANALYTE) | Normal Range Upper Limit | Float | Num | 14 | 8 | For Unit or Number-type Analytes | ||
| LBOVRDNRLO_(ANALYTE) | Normal Range Override Lower Limit | Float | Num | 14 | 8 | For Unit or Number-type Analytes | ||
| LBOVRDNRHI_(ANALYTE) | Normal Range Override Upper Limit | Float | Num | 14 | 8 | For Unit or Number-type Analytes | ||
| LBSTNRC_(ANALYTE) | Normal Value | Text | Char | $ | 1500 | $1500.00 | For Codelist or Text-type Analytes | |
| LBOVRDNRC_(ANALYTE) | Normal Value Override | Text | Char | $ | 1500 | $1500.00 | For Codelist or Text-type Analytes | |
| LBNRIND_(ANALYTE) | Normal Range Indicator | Text | Char | $ | 1500 | $1500.00 | ||
| LBCLSIG_(ANALYTE) | Clinical Significance | Text | Char | $ | 1500 | $1500.00 |
*This field refers to the Lab ID.
The LBDTC, LBLOC, and LBAGE columns are part of the Lab Header that is generated for each lab form. Each column related to a Lab Analyte has additional columns for the Unit (appended with _U), the Translated Value (appended with _TRANS), and the Translated Unit (appended with _TRANSU). For example, the Lab Result Unit for Sodium would display in the column header as LBORRES_Sodium_U.
Coding Data
If a form is set up for coding, meaning that a coding configuration has been defined in Studio, coding-related columns will be added after clinical data columns. If there are multiple verbatims set up in a form, the system will add a set of coding columns for each verbatim configured. If the same item in different item groups is configured for coding, the system will add “itemgroup.item” to each column header to indicate which set of columns belongs to which verbatim. Note that you need the View Code permission to view coding columns in the SDE.
List of coding columns for MedDRA:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 200 | $200 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 200 | $200 | |
| DICTVER | Dictionary Release | Text | Char | $ | 200 | $200 | |
| SOC | SOC | Text | Char | $ | 200 | $200 | |
| SOCID | SOC Code | Text | Char | $ | 200 | $200 | |
| HLGT | HLGT | Text | Char | $ | 200 | $200 | |
| HLGTID | HLGT Code | Text | Char | $ | 200 | $200 | |
| HLT | HLT | Text | Char | $ | 200 | $200 | |
| HLTID | HLT Code | Text | Char | $ | 200 | $200 | |
| PT | PT | Text | Char | $ | 200 | $200 | |
| PTID | PT Code | Text | Char | $ | 200 | $200 | |
| LLT | LLT | Text | Char | $ | 200 | $200 | |
| LLTID | LLT Code | Text | Char | $ | 200 | $200 | |
| PRIMPATH | Primary Path | Text | Char | $ | 200 | $200 | |
| LASTCODEDAT | Last Coded Date | Text | Char | $ | 200 | $200 | |
| LASTCODEBY | Last Coded By | Text | Char | $ | 200 | $200 |
List of coding columns for WHODrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 200 | $200 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 200 | $200 | |
| DICTVER | Dictionary Release | Text | Char | $ | 200 | $200 | |
| ATC1 | ATC1 | Text | Char | $ | 200 | $200 | |
| ATC1CD | ATC1 Code | Text | Char | $ | 200 | $200 | |
| ATC2 | ATC2 | Text | Char | $ | 200 | $200 | |
| ATC2CD | ATC2 Code | Text | Char | $ | 200 | $200 | |
| ATC3 | ATC3 | Text | Char | $ | 200 | $200 | |
| ATC3CD | ATC3 Code | Text | Char | $ | 200 | $200 | |
| ATC4 | ATC4 | Text | Char | $ | 200 | $200 | |
| ATC4CD | ATC4 Code | Text | Char | $ | 200 | $200 | |
| PREFNAME | Preferred Name | Text | Char | $ | 200 | $200 | |
| PREFCODE | Preferred Code | Text | Char | $ | 200 | $200 | |
| DRUGNAME | Drug Name | Text | Char | $ | 200 | $200 | |
| DRUGCODE | Drug Code | Text | Char | $ | 200 | $200 | |
| PREFBASE | Preferred Base Code | Text | Char | $ | 200 | $200 | |
| PREFLABEL | Preferred Base | Text | Char | $ | 200 | $200 | |
| LASTCODEDAT | Last Coded Date | Text | Char | $ | 200 | $200 | |
| LASTCODEBY | Last Coded By | Text | Char | $ | 200 | $200 |
List of coding columns for JDrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 200 | $200 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 200 | $200 | |
| DICTVER | Dictionary Release | Text | Char | $ | 200 | $200 | |
| DRUGCODE | Drug Code | Text | Char | $ | 200 | $200 | |
| DRUGNAME | Drug Name | Text | Char | $ | 200 | $200 | |
| GDRUGNAME | Generic Drug Name | Text | Char | $ | 200 | $200 | |
| DRUGCODECAT1 | Drug Code Category 1 | Text | Char | $ | 200 | $200 | |
| DRUGCODECAT2 | Drug Code Category 2 | Text | Char | $ | 200 | $200 | |
| USECAT1 | Use Category 1 | Text | Char | $ | 200 | $200 | |
| USECAT2 | Use Category 2 | Text | Char | $ | 200 | $200 | |
| MANNAME | Manufacturer Name | Text | Char | $ | 200 | $200 | |
| MANCODE | Manufacturer Code | Text | Char | $ | 200 | $200 | |
| MAINTFLG | Maintenance Flag | Text | Char | $ | 200 | $200 | |
| MAINTDT | Maintenance Date | Text | Char | $ | 200 | $200 | |
| LASTCODEDAT | Last Coded Date | Text | Char | $ | 200 | $200 | |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 200 | $200 |
Definitions File
The Study Data Extract ZIP file contains a definition file, which is a listing of all columns across all datasets included in the extract.
List of columns included in the Definitions file:
| Column Header | Data |
|---|---|
| Dataset Name | Name of the dataset |
| Column | Name of the column |
| Type | Item type for clinical data items |
| SAS Type | SAS type of the column |
| SAS Informat | SAS informat applied |
| SAS Format | SAS format applied |
| Length | Length in characters |
| SAS Length | SAS length in bytes |
| Label | SAS Label of the column |
System Datasets
Along with clinical datasets, the Study Data Extract file contains several system datasets that contain operational data and metrics.
SYS_SITE
The SYS_SITE dataset lists all sites for the selected study.
List of SYS_SITE columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | 100 | |
| COUNTRY | Study Country | Text | Char | $ | 100 | 100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | 100 | |
| SITENAME | Study Site Name | Text | Char | $ | 100 | 100 | |
| INVNAME | Principal Investigator | Text | Char | $ | 100 | 100 | |
| CASEBDEF | Casebook Version | Integer | Num | $ | 100 | 100 | |
| STATUS | Site Status | Text | Char | $ | 100 | 100 | |
| TIMEZONE | Timezone of the Site | Text | Char | $ | 100 | 100 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | 100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_SUB
The SYS_SUB dataset lists all subjects for the selected study.
List of SYS_SUB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | 100 | |
| COUNTRY | Country | Text | Char | $ | 100 | 100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | 100 | |
| SUBJID | Subject | Text | Char | $ | 100 | 100 | |
| CASEBDEF | Casebook Version | Integer | Num | $ | 100 | 100 | |
| STATUS | Status of the Subject/Casebook | Text | Char | $ | 100 | 100 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | 100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CNSNTDT | Initial Consent Date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| SCRDDT | Screened date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| SCRFAILDT | Screen failed date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| ENRDDT | Enrolled date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| RDMDDT | Randomized date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| STARTTRTDT | Started Treatment Date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| ENDTRTDT | End of treatment date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| WTHDRWNDT | Withdrawn date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| STARTFLLWUPDT | Started Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| LOSTFLLWUPDT | Lost to Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| CMPLTDT | End of study date | Date | Num | : vdate. | DATE9. | 14 | 9 |
SYS_EVT
The SYS_EVT dataset lists all events as well as event dates and status for the selected study.
List of SYS_EVT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTEID | Event External ID | Text | Char | $ | 200 | $200 | |
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9 | 14 | 8 |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | ||
| LASTMODDAT | Last modified date/time of the event date (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CASEBDEF | Casebook Version | Integer | Num | $ | 20 | $20 | |
| STATUS | Status of the event/visit | Text | Char | $ | 100 | $100 | |
| LASTREAS | Last change reason | Text | Char | $ | 200 | $200 | |
| WINSTAT | Scheduled Window Status | Text | Char | $ | 100 | $100 | |
| DAYSOW | Days Outside Window | Integer | Num | 14 | 8 | ||
| EXPFORMS | Expected Number of Forms | Integer | Num | 14 | 8 | ||
| FORMEOD | Number of days past due when one or more forms is not yet complete | Integer | Num | 14 | 8 | ||
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_FORM
The SYS_FORM dataset lists all forms for the selected study, including forms Intentionally Left Blank as well as review statuses, freeze and lock statuses, and additional metrics.
List of SYS_FORM columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | ||
| COUNTRY | Country | Text | Char | $ | 100 | $100 | ||
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | ||
| SUBJID | Subject | Text | Char | $ | 100 | $100 | ||
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | ||
| EVENT | Event | Text | Char | $ | 200 | $200 | ||
| EVENTEID | Event External Id | Text | Char | $ | 200 | $200 | ||
| EVENTDT | Event date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 200 | $200 | ||
| FORMEID | Form External ID | Text | Char | $ | 100 | $100 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| STATUS | Form Status | Text | Char | $ | 100 | $100 | ||
| CREATEDT | Datetime form created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| SUBMITDT | Datetime form last submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Number of times form was submitted | Integer | Num | 14 | 8 | |||
| SDVREQ | SDV Required | Boolean | Char | $ | 1 | $1 | Not supported for SDV rollup V1 studies, will be blank | |
| SDVDT | Datetime considered SDV complete (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| SDVLAST | Datetime of last SDV modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TOSDV | Days from submit to SDV | Float | Num | 14 | 8 | |||
| DMRREQ | DMR Required | Boolean | Char | $ | 1 | $1 | Not supported for SDV rollup V1 studies, will be blank | |
| DMRDT | Datetime considered DMR complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| DMRLAST | Datetime of last DMR modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | Not supported for SDV rollup V1 studies, will be blank |
| TODMR | Days from submit to DMR | Float | Num | 14 | 8 | |||
| FREEZEDT | Datetime frozen (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOFREEZE | Days from submit to freeze | Float | Num | 14 | 8 | |||
| LOCKDT | Datetime locked (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOLOCK | Days from submit to lock | Float | Num | 14 | 8 | |||
| SIGNDT | Datetime signed (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LSTSGNDT | Last Signature Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TOSIGN | Days from submit to sign | Float | Num | 14 | 8 | |||
| EDT_SUBM | Days from event date (of form) to submit date | Float | Num | 14 | 8 | |||
| ILB | Intentionally Left Blank | Boolean | Char | $ | 100 | $100 | ||
| ILBREAS | Reason for Intentionally Left Blank | Text | Char | $ | 200 | $200 | ||
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $100 | ||
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_Q
The SYS_Q dataset lists all queries for the selected study, along with some query metrics. Only the first query message is listed in this dataset. The full list of query messages (first message, answers, etc.) is included in the SYS_QT dataset.
List of SYS_Q columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | ||
| COUNTRY | Country | Text | Char | $ | 100 | $100 | ||
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | ||
| SUBJID | Subject | Text | Char | $ | 100 | $100 | ||
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | ||
| EVENT | Event | Text | Char | $ | 200 | $200 | ||
| EVENTEID | Event External Id | Text | Char | $ | 200 | $200 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 200 | $200 | ||
| FORMEID | Form External ID | Text | Char | $ | 100 | $100 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| ITEMGROUP | Item group | Text | Char | $ | 200 | $200 | ||
| IGSEQ | Item group sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| QUERYID | Query ID | Text | Char | $ | 200 | $200 | ||
| STATUS | Query status | Text | Char | $ | 100 | $100 | Includes Open, Answered, and Closed queries | |
| MANUAL | Manual query | Boolean | Char | $ | 200 | $200 | ||
| RULEID | Rule name | Text | Char | $ | 200 | $200 | ||
| TRIGID | Trigger name | Text | Char | $ | 200 | $200 | ||
| QTEXT | Initial query text/message | Text | Char | $ | 200 | $200 | ||
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created by | Text | Char | $ | 100 | $100 | ||
| QUERYTEAM | Query team | Text | Char | $ | 100 | $100 | ||
| QTFRESP | Time to first response (days) | Float | Num | 14 | 8 | Only populated when there's a First Response Date and the query has a status of "Answered" | ||
| QAGE | Query Age (days) | Float | Num | 14 | 8 | |||
| QCHGDATA | Whether the data changed after query creation (field query attached) | Boolean | Char | $ | 1 | $1 | ||
| QOTOCL | Query open to close (days) | Float | Num | 14 | 8 | |||
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $100 | ||
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_QT
The SYS_QT dataset lists all query messages for the selected study.
You can link the content of this file with the SYS_Q dataset using the QUERYID column. There can be multiple SYS_QT records matching one SYS_Q record (i.e. a query in SYS_Q can have multiple query messages in SYS_QT).
List of SYS_QT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | ||
| COUNTRY | Country | Text | Char | $ | 100 | $100 | ||
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | ||
| SUBJID | Subject | Text | Char | $ | 100 | $100 | ||
| QUERYID | Query ID | Text | Char | $ | 200 | $200 | ||
| STATUS | Query status | Text | Char | $ | 100 | $100 | Includes Open, Answered, Closed, and Reopened queries | |
| QTEXT | Initial query text/message | Text | Char | $ | 200 | $200 | ||
| TEXTDT | Text/Message Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| TEXTBY | Text/Message By | Text | Char | $ | 100 | $100 | ||
| QUERYTEAM | Query team | Text | Char | $ | 100 | $100 | ||
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $100 | ||
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ILB
The SYS_ILB dataset lists all items that have been marked Intentionally Left Blank in the selected study.
List of SYS_ILB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | ||
| COUNTRY | Country | Text | Char | $ | 100 | $100 | ||
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | ||
| SUBJID | Subject | Text | Char | $ | 100 | $100 | ||
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | ||
| EVENT | Event | Text | Char | $ | 200 | $200 | ||
| EVENTEID | Event External Id | Text | Char | $ | 200 | $200 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 200 | $200 | ||
| FORMEID | Form External ID | Text | Char | $ | 100 | $100 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 100 | $100 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 200 | $200 | ||
| LABANALYTENAME | Analyte Name | Text | Char | $ | 200 | $200 | Visible if Local Labs is enabled | |
| DATASETNAME | Dataset name | Text | Char | $ | 100 | $100 | ||
| ILBREAS | Reason for intentionally left blank | Text | Char | $ | 200 | $200 | ||
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $100 | ||
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LINKS
The SYS_LINKS dataset lists all forms that belong to a form link in the selected study. Forms that are linked together will share the same link ID, which will display in the GUID column. The form unique identifier (FGUID) can then be used to identify a specific form and access its data.
List of SYS_LINKS columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTEID | Event External Id | Text | Char | $ | 200 | $200 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 20 | $20 | |
| FORMEID | Form external ID | Text | Char | $ | 20 | $20 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | |
| IGROUPDEF | Item Group Definition | Text | Char | $ | 128 | $512 | |
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | ||
| ITEM | Item | Text | Char | $ | 500 | $2000 | |
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | |
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CREATEDB | Created by | Text | Char | $ | 100 | $100 | |
| FGUID | Internal vault ID (forms) | Text | Char | $ | 100 | $100 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime of when the extract was run (UTC) |
SYS_ASM
The SYS_ASM dataset lists the following information about assessments, if assessments are configured for a Study.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| ASMNAME | Assessment Name | Text | Char | $ | 200 | $200 | |
| ASMLABEL | Assessment Label | Text | Char | $ | 200 | $200 | |
| ASMTYPE | Assessment Type | Text | Char | $ | 200 | $200 | |
| SOURCEF | Source Form | Text | Char | $ | 200 | $200 | |
| STATUS | Status of Assessment | Text | Char | $ | 200 | $200 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| COMPDT | Completed Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| NSUBMITS | Submit Count | Integer | Num | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| GUID | Assessment Vault ID | Text | Char | $ | 100 | $100 | |
| FGUID | Source Form Vault ID | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASMR
The SYS_ASMR dataset lists questions and answers for all assessments in a Study, if assessments are configured.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| ASMLABEL | Assessment Label | Text | Char | $ | 200 | $200 | |
| QUESTEXT | Question Text | Text | Char | $ | 200 | $200 | |
| QUESANS | Question Answer | Text | Char | $ | 200 | $200 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| AGUID | Assessment Vault ID | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_PD
The SYS_PD dataset lists the following Protocol Deviations information, if Protocol Deviations is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| PDID | Protocol Deviation Identifier | Text | Char | $ | 200 | $200 | |
| PDSUM | Protocol Deviation Summary | Text | Char | $ | 1000 | $1000 | |
| PDDAT | Date of Deviation | Date | Num | : vdate. | DATE9. | 14 | 8 |
| PDDATID | Date Identified | Date | Num | : vdate. | DATE9. | 14 | 8 |
| PDCAT | Category | Text | Char | $ | 100 | $100 | |
| PDCATLABEL | Category Label | Text | Char | $ | 128 | 512 | |
| PDSUBCAT | Subcategory | Text | Char | $ | 100 | $100 | |
| PDSUBCATLABEL | Subcategory Label | Text | Char | $ | 128 | 512 | |
| PDSEV | Severity | Text | Char | $ | 100 | $100 | |
| PDSEVLABEL | Severity Label | Text | Char | $ | 128 | 512 | |
| PDDESC | Description | Text | Char | $ | 1000 | $1000 | |
| PDSTATUS | Protocol Deviation Status | Text | Char | $ | 100 | $100 | |
| PDRES | Protocol Deviation Resolution | Text | Char | $ | 500 | $2000 | |
| PDRULE | Protocol Deviation Rule | Text | Char | $ | 100 | $100 | |
| EGROUP | Event Group | Text | Char | $ | 100 | $100 | |
| EVENT | Event | Text | Char | $ | 100 | $100 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 100 | $100 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| IGROUP | Item Group | Text | Char | $ | 100 | $100 | |
| IGSEQ | Item Group Sequence | Integer | Num | $ | 100 | $100 | |
| ITEM | Item | Text | Char | $ | 500 | $2000 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CREATEDB | Created By | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| USERMODDT | User Modified Date | Text | Char | $ | 100 | $100 | |
| USERMODB | User Modified By | Text | Char | $ | 100 | $100 | |
| INACBYSYS | Inactivated by System | Boolean | Char | $ | 100 | $100 | |
| LASTINACDT | Last Inactivated Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| FGUID | Internal Vault ID of Form | Text | Char | $ | 100 | 400 | |
| PDGUID | Internal Vault ID of Protocol Deviation | Text | Char | $ | 15 | 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_RAND
The SYS_RAND dataset lists the following Randomization information, if Randomization is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | ||
| COUNTRY | Country | Text | Char | $ | 100 | $100 | ||
| SITE | Study Site Number | Text | Char | $ | 100 | $100 | ||
| SUBJID | Subject | Text | Char | $ | 100 | $100 | ||
| RANDSTATUS | Randomization Status | Text | Char | $ | 200 | $200 | ||
| RANDID | Randomization ID | Text | Char | $ | 200 | $200 | ||
| TREATMENTNAME* | Treatment Name | Text | Char | $ | 200 | $200 | ||
| TREATMENTLABEL* | Treatment Label | Text | Char | $ | 1500 | $1500 | ||
| TREATMENTARM* | Treatment Arm | Text | Char | $ | 200 | $200 | Visible if "Include Randomization Treatment" is selected in SDE Version 22R1 or later | |
| RANDSTRATA | Strata Group | Text | Char | $ | 200 | $200 | ||
| RANDBY | Randomized By | Text | Char | $ | 200 | $200 | ||
| RANDDAT | Randomized Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| RANDFILE | Randomization File Label | Text | Char | $ | 200 | $200 | ||
| RANDFILEDAT | Randomization File Upload Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
*These columns are only available for unmasked studies with Randomization enabled and users with the View Unmasked Data and View Randomization Enrollment permissions. To include these columns, check the Include Randomization Treatment box in the New Job dialog. Note that you can’t download SDE files from users with the View Randomization Enrollment permission if the Include Randomization Treatment checkbox is not visible to you in the SDE job dialog.
SYS_LABRANGES
The SYS_LABRANGES dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | |
| LABLOC | Lab Location | Text | Char | $ | 200 | $200 | |
| LABANALYTENAME | Analyte Name | Text | Char | $ | 200 | $200 | |
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 200 | $200 | |
| LABREFRSTATUS | Lab Reference Range Status | Text | Char | $ | 20 | $20 | |
| LABTESTCODE | Test Code | Text | Char | $ | 200 | $200 | |
| LABSEX | Sex | Text | Char | $ | 20 | $20 | |
| LABLOWERAGE | Lower Age | Integer | Num | 14 | 8 | ||
| LABUPPERAGE | Upper Age | Integer | Num | 14 | 8 | ||
| LABAGEUNIT | Age Unit | Text | Char | $ | 100 | $100 | |
| LABFEMCYCLE | Female Cycle | Text | Char | $ | 100 | $100 | |
| LABLNORMAL | Lower Normal | Float | Num | 14 | 8 | ||
| LABUNORMAL | Upper Normal | Float | Num | 14 | 8 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 100 | $100 | |
| LABMEASUNITLABEL | Measurement Unit Label | Text | Char | $ | 100 | $100 | |
| LABCODENORM | Codelist Normal | Text | Char | $ | 100 | $100 | |
| LABTEXTNORM | Text Normal | Text | Char | $ | 100 | $100 | |
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | 5 | |
| LABFROMDT | Effective From Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABTODT | Effective To Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABDESCR | Description | Text | Char | $ | 100 | $100 | |
| LABSPECTYPE | Specimen Type | Text | Char | $ | 100 | $100 | |
| LABTESTMET | Testing Method | Text | Char | $ | 100 | $100 | |
| CREATB | Created By | Text | Char | $ | 100 | $100 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LABLOC
The SYS_LABLOC dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | |
| LABLOC | Lab Location | Text | Char | $ | 200 | $200 | |
| LABLOCSTATUS | Lab Location Status | Text | Char | $ | 100 | $100 | |
| LABAPPROVED | Approved Lab Location | Text | Char | $ | 100 | $100 | |
| LABADDRESS | Lab Address | Text | Char | $ | 200 | $200 | |
| LABCOUNTRY | Lab Country | Text | Char | $ | 200 | $200 | |
| LABCONTACT | Lab Contact Name | Text | Char | $ | 200 | $200 | |
| LABCONTITLE | Lab Contact Title | Text | Char | $ | 200 | $200 | |
| LABTEL | Lab Telephone | Text | Char | $ | 20 | $20 | |
| LABFAX | Lab Fax | Text | Char | $ | 100 | $100 | |
| LABPRIMEMAIL | Lab Primary Email | Text | Char | $ | 100 | $100 | |
| LABSECMAIL | Lab Secondary Email | Text | Char | $ | 100 | $100 | |
| LABSTATUS | Lab Status | Text | Char | $ | 100 | $100 | |
| CREATEDB | Created By | Text | Char | $ | 100 | $100 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ANALYTES
The SYS_ANALYTES dataset lists the following Labs analyte information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABANALYTENAME | Analyte Name | Text | Char | $ | 200 | $200 | |
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 200 | $200 | |
| LABDESCR | Description | Text | Char | $ | 1000 | $1000 | |
| LABDATATYPE | Data Type | Text | Char | $ | 200 | $200 | |
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 200 | $200 | |
| LABCODELIST | Codelist | Text | Char | $ | 200 | $200 | |
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | 5 | |
| LABSPECTYPE | Specimen Type | Text | Char | $ | 200 | $200 | |
| LABLEN | Length | Integer | Num | 14 | 8 | ||
| LABPREC | Precision | Integer | Num | $ | 200 | $200 | |
| LABSYSMANAGED | System Managed | Boolean | Char | $ | 5 | 5 | |
| LABTESTMET | Testing Method | Text | Char | $ | 200 | $200 | |
| LABLOINC | LOINC Code | Text | Char | $ | 200 | $200 | |
| LABSDTMNM | SDTM Name | Text | Char | $ | 1000 | $1000 | |
| CREATEDB | Created By | Text | Char | $ | 100 | $100 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
22R1 Version
Clinical Datasets
Each clinical dataset, and each Form (Adverse Events, Concomitant Medications, etc.), contains a set of Key Columns and a set of Clinical Data columns, which are detailed below.
Key Columns
Key Columns contain data to help identify which Form each row is referring to (ex: which Subject, Site, Cycle, or Event that particular form is located in).
The list of Key Columns is as follows:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | ||
| COUNTRY | Country | Text | Char | $ | 100 | $100 | ||
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | ||
| SUBJID | Subject | Text | Char | $ | 100 | $100 | ||
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | ||
| EVENT | Event | Text | Char | $ | 200 | $200 | ||
| EVENTEID | Event External ID | Text | Char | $ | 200 | $200 | ||
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 200 | $200 | ||
| FORMEID | Form External ID | Text | Char | $ | 100 | $100 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| DLASTMOD* | Datetime of last data change (UTC). This field is derived by taking the most recent datetime from all of the items' value_modified_date__v on the form. | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 200 | $200 | ||
| IGGUID | Internal Vault ID (item groups) | Text | Char | $ | 1000 | $1000 | ||
| FORMILB | Intentionally Left Blank | Boolean | Char | $ | 1 | $1 | ||
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| (Form Link ItemDef Name)_DEF | [Form Link Item Label] Definition | Text | Char | $ | 200 | $800 | If Item to Form Linking is enabled. Format of the cell value: Form Label that is linked to the item. The Form Sequence (#X) is included if the form is repeating. | |
| (Form Link ItemDef Name)_LINKEDFORMID | [Form Link Item Label] Linked Form ID | Text | Char | $ | 100 | $400 | If Item to Form Linking is enabled | |
| LINKEDTO | Links to other forms | Text | Char | $ | 1500 | $1500 | If Item to Form Linking is enabled | |
| ITEMLINKEDTO | Item Linked To | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled | |
| LINKEDITEM | Linked Item | Text | Char | $ | 1500 | $6000 | If Item to Form Linking is enabled |
*Datetime columns can be separated into two separate Date and Time columns.
Lab Columns
Each form configured with Local Labs contains certain columns that are dynamically added after the LASTRUN column for lab items. Refer to the table below for a complete list of columns.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LBDTC | Collection Date Time | Datetime | Num | DATETIME22.3 | 14 | 8 | ||
| LBLOC | Lab Location* | Text | Char | $ | 1500 | $1500.00 | ||
| LBAGE | Age | Integer | Num | 14 | 8 | |||
| LBORRES_(ANALYTE) | Lab Result | Float | Num | 14 | 8 | |||
| LBORNRLO_(ANALYTE) | Normal Range Lower Limit | Float | Num | 14 | 8 | For Unit or Number-type Analytes | ||
| LBORNRHI_(ANALYTE) | Normal Range Upper Limit | Float | Num | 14 | 8 | For Unit or Number-type Analytes | ||
| LBOVRDNRLO_(ANALYTE) | Normal Range Override Lower Limit | Float | Num | 14 | 8 | For Unit or Number-type Analytes | ||
| LBOVRDNRHI_(ANALYTE) | Normal Range Override Upper Limit | Float | Num | 14 | 8 | For Unit or Number-type Analytes | ||
| LBNRIND_(ANALYTE) | Normal Range Indicator | Text | Char | $ | 1500 | $1500.00 | ||
| LBCLSIG_(ANALYTE) | Clinical Significance | Text | Char | $ | 1500 | $1500.00 |
*This field refers to the Lab ID.
The LBDTC, LBLOC, and LBAGE columns are part of the Lab Header that is generated for each lab form. Each column related to a Lab Analyte has additional columns for the Unit (appended with _U), the Translated Value (appended with _TRANS), and the Translated Unit (appended with _TRANSU). For example, the Lab Result Unit for Sodium would display in the column header as LBORRES_Sodium_U.
Coding Data
If a form is set up for coding, meaning that a coding configuration has been defined in Studio, coding-related columns will be added after clinical data columns. If there are multiple verbatims set up in a form, the system will add a set of coding columns for each verbatim configured. If the same item in different item groups is configured for coding, the system will add “itemgroup.item” to each column header to indicate which set of columns belongs to which verbatim.
List of coding columns for MedDRA:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 200 | $200 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 200 | $200 | |
| DICTVER | Dictionary Release | Text | Char | $ | 200 | $200 | |
| SOC | SOC | Text | Char | $ | 200 | $200 | |
| SOCID | SOC Code | Text | Char | $ | 200 | $200 | |
| HLGT | HLGT | Text | Char | $ | 200 | $200 | |
| HLGTID | HLGT Code | Text | Char | $ | 200 | $200 | |
| HLT | HLT | Text | Char | $ | 200 | $200 | |
| HLTID | HLT Code | Text | Char | $ | 200 | $200 | |
| PT | PT | Text | Char | $ | 200 | $200 | |
| PTID | PT Code | Text | Char | $ | 200 | $200 | |
| LLT | LLT | Text | Char | $ | 200 | $200 | |
| LLTID | LLT Code | Text | Char | $ | 200 | $200 | |
| PRIMPATH | Primary Path | Text | Char | $ | 200 | $200 | |
| LASTCODEDAT | Last Coded Date | Text | Char | $ | 200 | $200 | |
| LASTCODEBY | Last Coded By | Text | Char | $ | 200 | $200 |
List of coding columns for WHODrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 200 | $200 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 200 | $200 | |
| DICTVER | Dictionary Release | Text | Char | $ | 200 | $200 | |
| ATC1 | ATC1 | Text | Char | $ | 200 | $200 | |
| ATC1CD | ATC1 Code | Text | Char | $ | 200 | $200 | |
| ATC2 | ATC2 | Text | Char | $ | 200 | $200 | |
| ATC2CD | ATC2 Code | Text | Char | $ | 200 | $200 | |
| ATC3 | ATC3 | Text | Char | $ | 200 | $200 | |
| ATC3CD | ATC3 Code | Text | Char | $ | 200 | $200 | |
| ATC4 | ATC4 | Text | Char | $ | 200 | $200 | |
| ATC4CD | ATC4 Code | Text | Char | $ | 200 | $200 | |
| PREFNAME | Preferred Name | Text | Char | $ | 200 | $200 | |
| PREFCODE | Preferred Code | Text | Char | $ | 200 | $200 | |
| DRUGNAME | Drug Name | Text | Char | $ | 200 | $200 | |
| DRUGCODE | Drug Code | Text | Char | $ | 200 | $200 | |
| PREFBASE | Preferred Base Code | Text | Char | $ | 200 | $200 | |
| PREFLABEL | Preferred Base | Text | Char | $ | 200 | $200 | |
| LASTCODEDAT | Last Coded Date | Text | Char | $ | 200 | $200 | |
| LASTCODEBY | Last Coded By | Text | Char | $ | 200 | $200 |
List of coding columns for JDrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 200 | $200 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 200 | $200 | |
| DICTVER | Dictionary Release | Text | Char | $ | 200 | $200 | |
| DRUGCODE | Drug Code | Text | Char | $ | 200 | $200 | |
| DRUGNAME | Drug Name | Text | Char | $ | 200 | $200 | |
| GDRUGNAME | Generic Drug Name | Text | Char | $ | 200 | $200 | |
| DRUGCODECAT1 | Drug Code Category 1 | Text | Char | $ | 200 | $200 | |
| DRUGCODECAT2 | Drug Code Category 2 | Text | Char | $ | 200 | $200 | |
| USECAT1 | Use Category 1 | Text | Char | $ | 200 | $200 | |
| USECAT2 | Use Category 2 | Text | Char | $ | 200 | $200 | |
| MANNAME | Manufacturer Name | Text | Char | $ | 200 | $200 | |
| MANCODE | Manufacturer Code | Text | Char | $ | 200 | $200 | |
| MAINTFLG | Maintenance Flag | Text | Char | $ | 200 | $200 | |
| MAINTDT | Maintenance Date | Text | Char | $ | 200 | $200 | |
| LASTCODEDAT | Last Coded Date | Text | Char | $ | 200 | $200 | |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 200 | $200 |
Definitions File
The Study Data Extract ZIP file contains a definition file, which is a listing of all columns across all datasets included in the extract.
List of columns included in the Definitions file:
| Column Header | Data |
|---|---|
| Dataset Name | Name of the dataset |
| Column | Name of the column |
| Type | Item type for clinical data items |
| SAS Type | SAS type of the column |
| SAS Informat | SAS informat applied |
| SAS Format | SAS format applied |
| Length | Length in characters |
| SAS Length | SAS length in bytes |
| Label | SAS Label of the column |
System Datasets
Along with clinical datasets, the Study Data Extract file contains several system datasets that contain operational data and metrics.
SYS_SITE
The SYS_SITE dataset lists all sites for the selected study.
List of SYS_SITE columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | 100 | |
| COUNTRY | Study Country | Text | Char | $ | 100 | 100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | 100 | |
| SITENAME | Study Site Name | Text | Char | $ | 100 | 100 | |
| INVNAME | Principal Investigator | Text | Char | $ | 100 | 100 | |
| CASEBDEF | Casebook Version | Integer | Char | $ | 100 | 100 | |
| STATUS | Site Status | Text | Char | $ | 100 | 100 | |
| TIMEZONE | Timezone of the Site | Text | Char | $ | 100 | 100 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | 100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_SUB
The SYS_SUB dataset lists all subjects for the selected study.
List of SYS_SUB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | 100 | |
| COUNTRY | Country | Text | Char | $ | 100 | 100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | 100 | |
| SUBJID | Subject | Text | Char | $ | 100 | 100 | |
| CASEBDEF | Casebook Version | Integer | Char | $ | 100 | 100 | |
| STATUS | Status of the Subject/Casebook | Text | Char | $ | 100 | 100 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | 100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CNSNTDT | Initial Consent Date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| SCRDDT | Screened date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| SCRFAILDT | Screen failed date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| ENRDDT | Enrolled date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| RDMDDT | Randomized date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| STARTTRTDT | Started Treatment Date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| ENDTRTDT | End of treatment date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| WTHDRWNDT | Withdrawn date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| STARTFLLWUPDT | Started Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| LOSTFLLWUPDT | Lost to Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| CMPLTDT | End of study date | Date | Num | : vdate. | DATE9. | 14 | 9 |
SYS_EVT
The SYS_EVT dataset lists all events as well as event dates and status for the selected study.
List of SYS_EVT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTEID | Event External ID | Text | Char | $ | 200 | $200 | |
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9 | 14 | 8 |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | ||
| LASTMODDT | Last modified date/time of the event date (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CASEBDEF | Casebook Version | Integer | Char | $ | 20 | $20 | |
| STATUS | Status of the event/visit | Text | Char | $ | 100 | $100 | |
| LASTREAS | Last change reason | Text | Char | $ | 200 | $200 | |
| WINSTAT | Scheduled Window Status | Text | Char | $ | 100 | $100 | |
| DAYSOW | Days Outside Window | Integer | Num | 14 | 8 | ||
| EXPFORMS | Expected Number of Forms | Integer | Num | 14 | 8 | ||
| FORMEOD | Number of days past due when one or more forms is not yet complete | Integer | Num | 14 | 8 | ||
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_FORM
The SYS_FORM dataset lists all forms for the selected study, including forms Intentionally Left Blank as well as review statuses, freeze and lock statuses, and additional metrics.
List of SYS_FORM columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTEID | Event External Id | Text | Char | $ | 200 | $200 | |
| EVENTDT | Event date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 200 | $200 | |
| FORMEID | Form External ID | Text | Char | $ | 100 | $100 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| STATUS | Form Status | Text | Char | $ | 100 | $100 | |
| CREATEDT | Datetime form created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| SUBMITDT | Datetime form last submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| NSUBMITS | Number of times form was submitted | Integer | Num | 14 | 8 | ||
| SDVREQ | SDV Required | Boolean | Char | $ | 1 | $1 | |
| SDVDT | Datetime considered SDV complete (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| SDVLAST | Datetime of last SDV modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TOSDV | Days from submit to SDV | Float | Num | 14 | 8 | ||
| DMRREQ | DMR Required | Boolean | Char | $ | 1 | $1 | |
| DMRDT | Datetime considered DMR complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| DMRLAST | Datetime of last DMR modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TODMR | Days from submit to DMR | Float | Num | 14 | 8 | ||
| FREEZEDT | Datetime frozen (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TOFREEZE | Days from submit to freeze | Float | Num | 14 | 8 | ||
| LOCKDT | Datetime locked (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TOLOCK | Days from submit to lock | Float | Num | 14 | 8 | ||
| SIGNDT | Datetime signed (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LSTSGNDT | Last Signature Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TOSIGN | Days from submit to sign | Integer | Num | 14 | 8 | ||
| EDT_SUBM | Days from event date (of form) to submit date | Float | Num | 14 | 8 | ||
| ILB | Intentionally Left Blank | Boolean | Char | $ | 100 | $100 | |
| ILBREAS | Reason for Intentionally Left Blank | Text | Char | $ | 200 | $200 | |
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_Q
The SYS_Q dataset lists all queries for the selected study, along with some query metrics. Only the first query message is listed in this dataset. The full list of query messages (first message, answers, etc.) is included in the SYS_QT dataset.
List of SYS_Q columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTEID | Event External Id | Text | Char | $ | 200 | $200 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 200 | $200 | |
| FORMEID | Form External ID | Text | Char | $ | 100 | $100 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| ITEMGROUP | Item group | Text | Char | $ | 200 | $200 | |
| IGSEQ | Item group sequence | Integer | Num | 14 | 8 | ||
| ITEM | Item | Text | Char | $ | 500 | $2000 | |
| QUERYID | Query ID | Text | Char | $ | 200 | $200 | |
| STATUS | Query status | Text | Char | $ | 100 | $100 | |
| MANUAL | Manual query | Text | Char | $ | 200 | $200 | |
| RULEID | Rule name | Text | Char | $ | 200 | $200 | |
| TRIGID | Trigger name | Text | Char | $ | 200 | $200 | |
| QTEXT | Initial query text/message | Text | Char | $ | 200 | $200 | |
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CREATEDB | Created by | Text | Char | $ | 100 | $100 | |
| QUERYTEAM | Query team | Text | Char | $ | 100 | $100 | |
| QTFRESP | Time to first response (days) | Float | Num | 14 | 8 | ||
| QAGE | Query Age (days) | Float | Num | 14 | 8 | ||
| QCHGDATA | Whether the data changed after query creation (field query attached) | Boolean | Char | $ | 1 | $1 | |
| QOTOCL | Query open to close (days) | Float | Num | 14 | 8 | ||
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_QT
The SYS_QT dataset lists all query messages for the selected study.
You can link the content of this file with the SYS_Q dataset using the QUERYID column. There can be multiple SYS_QT records matching one SYS_Q record (i.e. a query in SYS_Q can have multiple query messages in SYS_QT).
List of SYS_QT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| QUERYID | Query ID | Text | Char | $ | 200 | $200 | |
| STATUS | Query status | Text | Char | $ | 100 | $100 | |
| QTEXT | Initial query text/message | Text | Char | $ | 200 | $200 | |
| TEXTDT | Text/Message Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TEXTBY | Text/Message By | Text | Char | $ | 100 | $100 | |
| QUERYTEAM | Query team | Text | Char | $ | 100 | $100 | |
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ILB
The SYS_ILB dataset lists all items that have been marked Intentionally Left Blank in the selected study.
List of SYS_ILB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTEID | Event External Id | Text | Char | $ | 200 | $200 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 200 | $200 | |
| FORMEID | Form External ID | Text | Char | $ | 100 | $100 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| IGROUP | Item Group | Text | Char | $ | 100 | $100 | |
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | ||
| ITEM | Item | Text | Char | $ | 500 | $2000 | |
| ITEMDEF | Item Definition | Text | Char | $ | 200 | $200 | |
| LABANALYTENAME | Analyte Name | Text | Char | $ | 200 | $200 | |
| DATASETNAME | Dataset name | Text | Char | $ | 100 | $100 | |
| ILBREAS | Reason for intentionally left blank | Text | Char | $ | 200 | $200 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LINKS
The SYS_LINKS dataset lists all forms that belong to a form link in the selected study. Forms that are linked together will share the same link ID, which will display in the GUID column. The form unique identifier (FGUID) can then be used to identify a specific form and access its data.
List of SYS_LINKS columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITE | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EGROUP | Event group | Text | Char | $ | 200 | $200 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTEID | Event external ID | Text | Char | $ | 200 | $200 | |
| ESEQ | Event Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 20 | $20 | |
| FORMEID | Form external ID | Text | Char | $ | 20 | $20 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CREATEDB | Created by | Text | Char | $ | 100 | $100 | |
| FGUID | Internal vault ID (forms) | Text | Char | $ | 100 | $100 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASM
The SYS_ASM dataset lists the following information about assessments, if assessments are configured for a Study.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| ASMNAME | Assessment Name | Text | Char | $ | 200 | $200 | |
| ASMLABEL | Assessment Label | Text | Char | $ | 200 | $200 | |
| ASMTYPE | Assessment Type | Text | Char | $ | 200 | $200 | |
| SOURCEF | Source Form | Text | Char | $ | 200 | $200 | |
| STATUS | Status of Assessment | Text | Char | $ | 200 | $200 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| COMPDT | Completed Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| NSUBMITS | Submit Count | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| GUID | Assessment Vault ID | Text | Char | $ | 100 | $100 | |
| FGUID | Source Form Vault ID | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASMR
The SYS_ASMR dataset lists questions and answers for all assessments in a Study, if assessments are configured.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| ASMLABEL | Assessment Label | Text | Char | $ | 200 | $200 | |
| QUESTEXT | Question Text | Text | Char | $ | 200 | $200 | |
| QUESANS | Question Answer | Text | Char | $ | 200 | $200 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| AGUID | Assessment Vault ID | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_PD
The SYS_PD dataset lists the following Protocol Deviations information, if Protocol Deviations is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| PDID | Protocol Deviation Identifier | Text | Char | $ | 200 | $200 | |
| PDSUM | Protocol Deviation Summary | Text | Char | $ | 1000 | $1000 | |
| PDDAT | Date of Deviation | Date | Num | : vdate. | DATE9. | 14 | 8 |
| PDDATID | Date Identified | Date | Num | : vdate. | DATE9. | 14 | 8 |
| PDCAT | Category | Text | Char | $ | 100 | $100 | |
| PDSUBCAT | Subcategory | Text | Char | $ | 100 | $100 | |
| PDSEV | Severity | Text | Char | $ | 100 | $100 | |
| PDDESC | Description | Text | Char | $ | 1000 | $1000 | |
| PDSTATUS | Protocol Deviation Status | Text | Char | $ | 100 | $100 | |
| PDRES | Protocol Deviation Resolution | Text | Char | $ | 500 | $2000 | |
| PDRULE | Protocol Deviation Rule | Text | Char | $ | 100 | $100 | |
| EGROUP | Event Group | Text | Char | $ | 100 | $100 | |
| EVENT | Event | Text | Char | $ | 100 | $100 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 100 | $100 | |
| IGROUP | Item Group | Text | Char | $ | 100 | $100 | |
| IGSEQ | Item Group Sequence | Text | Char | $ | 100 | $100 | |
| ITEM | Item | Text | Char | $ | 500 | $2000 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CREATEDB | Created By | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| USERMODDT | User Modified Date | Text | Char | $ | 100 | $100 | |
| USERMODB | User Modified By | Text | Char | $ | 100 | $100 | |
| INACBYSYS | Inactivated by System | Text | Char | $ | 100 | $100 | |
| LASTINACDT | Last Inactivated Date | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_RAND
The SYS_RAND dataset lists the following Randomization information, if Randomization is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | ||
| COUNTRY | Country | Text | Char | $ | 100 | $100 | ||
| SITE | Study Site Number | Text | Char | $ | 100 | $100 | ||
| SUBJID | Subject | Text | Char | $ | 100 | $100 | ||
| RANDSTATUS | Randomization Status | Text | Char | $ | 200 | $200 | ||
| RANDID | Randomization ID | Text | Char | $ | 200 | $200 | ||
| TREATMENTNAME* | Treatment Name | Text | Char | $ | 200 | $200 | ||
| TREATMENTLABEL* | Treatment Label | Text | Char | $ | 1500 | $1500 | ||
| TREATMENTARM* | Treatment Arm | Text | Char | $ | 200 | $200 | Visible if "Include Randomization Treatment" is selected in SDE Version 22R1 or later | |
| RANDSTRATA | Strata Group | Text | Char | $ | 200 | $200 | ||
| RANDBY | Randomized By | Text | Char | $ | 200 | $200 | ||
| RANDDAT | Randomized Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| RANDFILE | Randomization File Label | Text | Char | $ | 200 | $200 | ||
| RANDFILEDAT | Randomization File Upload Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
*These columns are only available for unmasked studies with Randomization enabled. To include these columns, check the Include Randomization Treatment box in the New Job dialog.
SYS_LABRANGES
The SYS_LABRANGES dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | |
| LABLOC | Lab Location | Text | Char | $ | 200 | $200 | |
| LABANALYTENAME | Analyte Name | Text | Char | $ | 200 | $200 | |
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 200 | $200 | |
| LABREFRSTATUS | Lab Reference Range Status | Text | Char | $ | 20 | $20 | |
| LABTESTCODE | Test Code | Text | Char | $ | 200 | $200 | |
| LABSEX | Sex | Text | Char | $ | 20 | $20 | |
| LABLOWERAGE | Lower Age | Integer | Num | 14 | 8 | ||
| LABUPPERAGE | Upper Age | Integer | Num | 14 | 8 | ||
| LABAGEUNIT | Age Unit | Text | Char | $ | 100 | $100 | |
| LABFEMCYCLE | Female Cycle | Text | Char | $ | 100 | $100 | |
| LABLNORMAL | Lower Normal | Float | Num | 14 | 8 | ||
| LABUNORMAL | Upper Normal | Float | Num | 14 | 8 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 100 | $100 | |
| LABMEASUNITLABEL | Measurement Unit Label | Text | Char | $ | 100 | $100 | |
| LABCODENORM | Codelist Normal | Text | Char | $ | 100 | $100 | |
| LABTEXTNORM | Text Normal | Text | Char | $ | 100 | $100 | |
| LABMODIFIER | Lab Modifier | Text | Char | $ | 5 | 5 | |
| LABFROMDT | Effective From Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABTODT | Effective To Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABDESCR | Description | Text | Char | $ | 100 | $100 | |
| LABSPECTYPE | Specimen Type | Text | Char | $ | 100 | $100 | |
| LABTESTMET | Testing Method | Text | Char | $ | 100 | $100 | |
| CREATB | Created By | Text | Char | $ | 100 | $100 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LABLOC
The SYS_LABLOC dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 128 | $512 | |
| LABLOC | Lab Location | Text | Char | $ | 200 | $200 | |
| LABLOCSTATUS | Lab Location Status | Text | Char | $ | 100 | $100 | |
| LABAPPROVED | Approved Lab Location | Text | Char | $ | 100 | $100 | |
| LABADDRESS | Lab Address | Text | Char | $ | 200 | $200 | |
| LABCOUNTRY | Lab Country | Text | Char | $ | 200 | $200 | |
| LABCONTACT | Lab Contact Name | Text | Char | $ | 200 | $200 | |
| LABCONTITLE | Lab Contact Title | Text | Char | $ | 200 | $200 | |
| LABTEL | Lab Telephone | Text | Char | $ | 20 | $20 | |
| LABFAX | Lab Fax | Text | Char | $ | 100 | $100 | |
| LABPRIMEMAIL | Lab Primary Email | Text | Char | $ | 100 | $100 | |
| LABSECMAIL | Lab Secondary Email | Text | Char | $ | 100 | $100 | |
| LABSTATUS | Lab Status | Text | Char | $ | 100 | $100 | |
| CREATEDB | Created By | Text | Char | $ | 100 | $100 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ANALYTES
The SYS_ANALYTES dataset lists the following Labs analyte information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABANALYTENAME | Analyte Name | Text | Char | $ | 200 | $200 | |
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 200 | $200 | |
| LABDESCR | Description | Text | Char | $ | 1000 | $1000 | |
| LABDATATYPE | Data Type | Text | Char | $ | 200 | $200 | |
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 200 | $200 | |
| LABCODELIST | Codelist | Text | Char | $ | 200 | $200 | |
| LABMODIFIER | Lab Modifier | Text | Char | $ | 5 | 5 | |
| LABSPECTYPE | Specimen Type | Text | Char | $ | 200 | $200 | |
| LABLEN | Length | Integer | Num | 14 | 8 | ||
| LABPREC | Precision | Text | Char | $ | 200 | $200 | |
| LABSYSMANAGED | System Managed | Text | Char | $ | 5 | 5 | |
| LABTESTMET | Testing Method | Text | Char | $ | 200 | $200 | |
| LABLOINC | LOINC Code | Text | Char | $ | 200 | $200 | |
| LABSDTMNM | SDTM Name | Text | Char | $ | 1000 | $1000 | |
| CREATEDB | Created By | Text | Char | $ | 100 | $100 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
21R3 Version
Clinical Datasets
Each clinical dataset, and each Form (Adverse Events, Concomitant Medications, etc.), contains a set of Key Columns and a set of Clinical Data columns, which are detailed below.
Key Columns
Key Columns contain data to help identify which Form each row is referring to (ex: which Subject, Site, Cycle, or Event that particular form is located in).
The list of Key Columns is as follows:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTEID | Event External ID | Text | Char | $ | 200 | $200 | |
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| ESEQ | Event Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 200 | $200 | |
| FORMEID | Form External ID | Text | Char | $ | 100 | $100 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | ||
| DLASTMOD* | Datetime of Last Data Change (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 200 | $200 | |
| IGGUID | Internal Vault ID (item groups) | Text | Char | $ | 1000 | $1000 | |
| FORMILB | Intentionally Left Blank | Boolean | Char | $ | 1 | $1 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LINKEDTO | Links to other forms | Text | Char | $ | 1500 | $1500 | |
| (ITEMNAME) | (Item Label) | Datetime | Num | $ | 14 | $200 | |
| (ITEMNAME)_UTC | (Item Label)_UTC | Datetime | Num | : vdatetime. | 14 | 8 | |
| (ITEMNAME)_USER | (Item Label)_USER | Datetime | Num | $ | 14 | $200 |
*Datetime columns can be separated into two separate Date and Time columns.
Coding Data
If a form is set up for coding, meaning that a coding configuration has been defined in Studio, coding-related columns will be added after clinical data columns. If there are multiple verbatims set up in a form, the system will add a set of coding columns for each verbatim configured. If the same item in different item groups is configured for coding, the system will add “itemgroup.item” to each column header to indicate which set of columns belongs to which verbatim.
List of coding columns for MedDRA:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 200 | $200 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 200 | $200 | |
| DICTVER | Dictionary Release | Text | Char | $ | 200 | $200 | |
| SOC | SOC | Text | Char | $ | 200 | $200 | |
| SOCID | SOC Code | Text | Char | $ | 200 | $200 | |
| HLGT | HLGT | Text | Char | $ | 200 | $200 | |
| HLGTID | HLGT Code | Text | Char | $ | 200 | $200 | |
| HLT | HLT | Text | Char | $ | 200 | $200 | |
| HLTID | HLT Code | Text | Char | $ | 200 | $200 | |
| PT | PT | Text | Char | $ | 200 | $200 | |
| PTID | PT Code | Text | Char | $ | 200 | $200 | |
| LLT | LLT | Text | Char | $ | 200 | $200 | |
| LLTID | LLT Code | Text | Char | $ | 200 | $200 | |
| PRIMPATH | Primary Path | Text | Char | $ | 200 | $200 | |
| LASTCODEDAT | Last Coded Date | Text | Char | $ | 200 | $200 | |
| LASTCODEBY | Last Coded By | Text | Char | $ | 200 | $200 |
List of coding columns for WHODrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 200 | $200 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 200 | $200 | |
| DICTVER | Dictionary Release | Text | Char | $ | 200 | $200 | |
| ATC1 | ATC1 | Text | Char | $ | 200 | $200 | |
| ATC1CD | ATC1 Code | Text | Char | $ | 200 | $200 | |
| ATC2 | ATC2 | Text | Char | $ | 200 | $200 | |
| ATC2CD | ATC2 Code | Text | Char | $ | 200 | $200 | |
| ATC3 | ATC3 | Text | Char | $ | 200 | $200 | |
| ATC3CD | ATC3 Code | Text | Char | $ | 200 | $200 | |
| ATC4 | ATC4 | Text | Char | $ | 200 | $200 | |
| ATC4CD | ATC4 Code | Text | Char | $ | 200 | $200 | |
| PREFNAME | Preferred Name | Text | Char | $ | 200 | $200 | |
| PREFCODE | Preferred Code | Text | Char | $ | 200 | $200 | |
| DRUGNAME | Drug Name | Text | Char | $ | 200 | $200 | |
| DRUGCODE | Drug Code | Text | Char | $ | 200 | $200 | |
| PREFBASE | Preferred Base Code | Text | Char | $ | 200 | $200 | |
| PREFLABEL | Preferred Base | Text | Char | $ | 200 | $200 | |
| LASTCODEDAT | Last Coded Date | Text | Char | $ | 200 | $200 | |
| LASTCODEBY | Last Coded By | Text | Char | $ | 200 | $200 |
List of coding columns for JDrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 200 | $200 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 200 | $200 | |
| DICTVER | Dictionary Release | Text | Char | $ | 200 | $200 | |
| DRUGCODE | Drug Code | Text | Char | $ | 200 | $200 | |
| DRUGNAME | Drug Name | Text | Char | $ | 200 | $200 | |
| GDRUGNAME | Generic Drug Name | Text | Char | $ | 200 | $200 | |
| DRUGCODECAT1 | Drug Code Category 1 | Text | Char | $ | 200 | $200 | |
| DRUGCODECAT2 | Drug Code Category 2 | Text | Char | $ | 200 | $200 | |
| USECAT1 | Use Category 1 | Text | Char | $ | 200 | $200 | |
| USECAT2 | Use Category 2 | Text | Char | $ | 200 | $200 | |
| MANNAME | Manufacturer Name | Text | Char | $ | 200 | $200 | |
| MANCODE | Manufacturer Code | Text | Char | $ | 200 | $200 | |
| MAINTFLG | Maintenance Flag | Text | Char | $ | 200 | $200 | |
| MAINTDT | Maintenance Date | Text | Char | $ | 200 | $200 | |
| LASTCODEDAT | Last Coded Date | Text | Char | $ | 200 | $200 | |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 200 | $200 |
Definitions File
The Study Data Extract ZIP file contains a definition file, which is a listing of all columns across all datasets included in the extract.
List of columns included in the Definitions file:
| Column Header | Data |
|---|---|
| Dataset Name | Name of the dataset |
| Column | Name of the column |
| Type | Item type for clinical data items |
| SAS Type | SAS type of the column |
| SAS Informat | SAS informat applied |
| SAS Format | SAS format applied |
| Length | Length in characters |
| SAS Length | SAS length in bytes |
| Label | SAS Label of the column |
System Datasets
SYS_SITE
The SYS_SITE dataset lists all sites for the selected study.
List of SYS_SITE columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | 100 | |
| COUNTRY | Study Country | Text | Char | $ | 100 | 100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | 100 | |
| SITENAME | Study Site Name | Text | Char | $ | 100 | 100 | |
| INVNAME | Principal Investigator | Text | Char | $ | 100 | 100 | |
| CASEBDEF | Casebook Version | Integer | Char | $ | 100 | 100 | |
| STATUS | Site Status | Text | Char | $ | 100 | 100 | |
| TIMEZONE | Timezone of the Site | Text | Char | $ | 100 | 100 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | 100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_SUB
The SYS_SUB dataset lists all subjects for the selected study.
List of SYS_SUB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | 100 | |
| COUNTRY | Country | Text | Char | $ | 100 | 100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | 100 | |
| SUBJID | Subject | Text | Char | $ | 100 | 100 | |
| CASEBDEF | Casebook Version | Integer | Char | $ | 100 | 100 | |
| STATUS | Status of the Subject/Casebook | Text | Char | $ | 100 | 100 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | 100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CNSNTDT | Initial Consent Date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| SCRDDT | Screened date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| SCRFAILDT | Screen failed date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| ENRDDT | Enrolled date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| RDMDDT | Randomized date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| STARTTRTDT | Started Treatment Date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| ENDTRTDT | End of treatment date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| WTHDRWNDT | Withdrawn date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| STARTFLLWUPDT | Started Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| LOSTFLLWUPDT | Lost to Follow Up Date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| CMPLTDT | End of study date | Date | Num | : vdate. | DATE9. | 14 | 9 |
SYS_EVT
The SYS_EVT dataset lists all events as well as event dates and status for the selected study.
List of SYS_EVT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTEID | Event External ID | Text | Char | $ | 200 | $200 | |
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9 | 14 | 8 |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | ||
| LASTMODDT | Last modified date/time of the event date (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CASEBDEF | Casebook Version | Integer | Char | $ | 20 | $20 | |
| STATUS | Status of the event/visit | Text | Char | $ | 100 | $100 | |
| LASTREAS | Last change reason | Text | Char | $ | 200 | $200 | |
| WINSTAT | Scheduled Window Status | Text | Char | $ | 100 | $100 | |
| DAYSOW | Days Outside Window | Integer | Num | 14 | 8 | ||
| EXPFORMS | Expected Number of Forms | Integer | Num | 14 | 8 | ||
| FORMEOD | Number of days past due when one or more forms is not yet complete | Integer | Num | 14 | 8 | ||
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_FORM
The SYS_FORM dataset lists all forms for the selected study, including forms Intentionally Left Blank as well as review statuses, freeze and lock statuses, and additional metrics.
List of SYS_FORM columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTEID | Event External Id | Text | Char | $ | 200 | $200 | |
| EVENTDT | Event date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 200 | $200 | |
| FORMEID | Form External ID | Text | Char | $ | 100 | $100 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| STATUS | Form Status | Text | Char | $ | 100 | $100 | |
| CREATEDT | Datetime form created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| SUBMITDT | Datetime form last submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| NSUBMITS | Number of times form was submitted | Integer | Num | 14 | 8 | ||
| SDVREQ | SDV Required | Boolean | Char | $ | 1 | $1 | |
| SDVDT | Datetime considered SDV complete (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| SDVLAST | Datetime of last SDV modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TOSDV | Days from submit to SDV | Float | Num | 14 | 8 | ||
| DMRREQ | DMR Required | Boolean | Char | $ | 1 | $1 | |
| DMRDT | Datetime considered DMR complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| DMRLAST | Datetime of last DMR modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TODMR | Days from submit to DMR | Float | Num | 14 | 8 | ||
| FREEZEDT | Datetime frozen (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TOFREEZE | Days from submit to freeze | Float | Num | 14 | 8 | ||
| LOCKDT | Datetime locked (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TOLOCK | Days from submit to lock | Float | Num | 14 | 8 | ||
| SIGNDT | Datetime signed (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LSTSGNDT | Last Signature Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TOSIGN | Days from submit to sign | Integer | Num | 14 | 8 | ||
| EDT_SUBM | Days from event date (of form) to submit date | Float | Num | 14 | 8 | ||
| ILB | Intentionally Left Blank | Boolean | Char | $ | 100 | $100 | |
| ILBREAS | Reason for Intentionally Left Blank | Text | Char | $ | 200 | $200 | |
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_Q
The SYS_Q dataset lists all queries for the selected study, along with some query metrics. Only the first query message is listed in this dataset. The full list of query messages (first message, answers, etc.) is included in the SYS_QT dataset.
List of SYS_Q columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTEID | Event External Id | Text | Char | $ | 200 | $200 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 200 | $200 | |
| FORMEID | Form External ID | Text | Char | $ | 100 | $100 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| ITEMGROUP | Item group | Text | Char | $ | 200 | $200 | |
| IGSEQ | Item group sequence | Integer | Num | 14 | 8 | ||
| ITEM | Item | Text | Char | $ | 200 | $200 | |
| QUERYID | Query ID | Text | Char | $ | 200 | $200 | |
| STATUS | Query status | Text | Char | $ | 100 | $100 | |
| MANUAL | Manual query | Text | Char | $ | 200 | $200 | |
| RULEID | Rule name | Text | Char | $ | 200 | $200 | |
| TRIGID | Trigger name | Text | Char | $ | 200 | $200 | |
| QTEXT | Initial query text/message | Text | Char | $ | 200 | $200 | |
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CREATEDB | Created by | Text | Char | $ | 100 | $100 | |
| QUERYTEAM | Query team | Text | Char | $ | 100 | $100 | |
| QTFRESP | Time to first response (days) | Float | Num | 14 | 8 | ||
| QAGE | Query Age (days) | Float | Num | 14 | 8 | ||
| QCHGDATA | Whether the data changed after query creation (field query attached) | Boolean | Char | $ | 1 | $1 | |
| QOTOCL | Query open to close (days) | Float | Num | 14 | 8 | ||
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_QT
The SYS_QT dataset lists all query messages for the selected study.
You can link the content of this file with the SYS_Q dataset using the QUERYID column. There can be multiple SYS_QT records matching one SYS_Q record (i.e. a query in SYS_Q can have multiple query messages in SYS_QT).
List of SYS_QT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| QUERYID | Query ID | Text | Char | $ | 200 | $200 | |
| STATUS | Query status | Text | Char | $ | 100 | $100 | |
| QTEXT | Initial query text/message | Text | Char | $ | 200 | $200 | |
| TEXTDT | Text/Message Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TEXTBY | Text/Message By | Text | Char | $ | 100 | $100 | |
| QUERYTEAM | Query team | Text | Char | $ | 100 | $100 | |
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ILB
The SYS_ILB dataset lists all items that have been marked Intentionally Left Blank in the selected study.
List of SYS_ILB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTEID | Event External Id | Text | Char | $ | 200 | $200 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 200 | $200 | |
| FORMEID | Form External ID | Text | Char | $ | 100 | $100 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| IGROUP | Item Group | Text | Char | $ | 100 | $100 | |
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | ||
| ITEM | Item | Text | Char | $ | 200 | $200 | |
| ITEMDEF | Item Definition | Text | Char | $ | 200 | $200 | |
| LABANALYTENAME | Analyte Name | Text | Char | $ | 200 | $200 | |
| DATASETNAME | Dataset name | Text | Char | $ | 100 | $100 | |
| ILBREAS | Reason for intentionally left blank | Text | Char | $ | 200 | $200 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LINKS
The SYS_LINKS dataset lists all forms that belong to a form link in the selected study. Forms that are linked together will share the same link ID, which will display in the GUID column. The form unique identifier (FGUID) can then be used to identify a specific form and access its data.
List of SYS_LINKS columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITE | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EGROUP | Event group | Text | Char | $ | 200 | $200 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTEID | Event external ID | Text | Char | $ | 200 | $200 | |
| ESEQ | Event Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 20 | $20 | |
| FORMEID | Form external ID | Text | Char | $ | 20 | $20 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CREATEDB | Created by | Text | Char | $ | 100 | $100 | |
| FGUID | Internal vault ID (forms) | Text | Char | $ | 100 | $100 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASM
The SYS_ASM dataset lists the following information about assessments, if assessments are configured for a Study.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| ASMNAME | Assessment Name | Text | Char | $ | 200 | $200 | |
| ASMLABEL | Assessment Label | Text | Char | $ | 200 | $200 | |
| ASMTYPE | Assessment Type | Text | Char | $ | 200 | $200 | |
| SOURCEF | Source Form | Text | Char | $ | 200 | $200 | |
| STATUS | Status of Assessment | Text | Char | $ | 200 | $200 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| COMPDT | Completed Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| NSUBMITS | Submit Count | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| GUID | Assessment Vault ID | Text | Char | $ | 100 | $100 | |
| FGUID | Source Form Vault ID | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASMR
The SYS_ASMR dataset lists questions and answers for all assessments in a Study, if assessments are configured.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| ASMLABEL | Assessment Label | Text | Char | $ | 200 | $200 | |
| QUESTEXT | Question Text | Text | Char | $ | 200 | $200 | |
| QUESANS | Question Answer | Text | Char | $ | 200 | $200 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| AGUID | Assessment Vault ID | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_PD
The SYS_PD dataset lists the following Protocol Deviations information, if Protocol Deviations is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| PDID | Protocol Deviation Identifier | Text | Char | $ | 200 | $200 | |
| PDSUM | Protocol Deviation Summary | Text | Char | $ | 1000 | $1000 | |
| PDDAT | Date of Deviation | Date | Num | : vdate. | DATE9. | 14 | 8 |
| PDDATID | Date Identified | Date | Num | : vdate. | DATE9. | 14 | 8 |
| PDCAT | Category | Text | Char | $ | 100 | $100 | |
| PDSUBCAT | Subcategory | Text | Char | $ | 100 | $100 | |
| PDSEV | Severity | Text | Char | $ | 100 | $100 | |
| PDDESC | Description | Text | Char | $ | 1000 | $1000 | |
| PDSTATUS | Protocol Deviation Status | Text | Char | $ | 100 | $100 | |
| PDRES | Protocol Deviation Resolution | Text | Char | $ | 100 | $100 | |
| PDRULE | Protocol Deviation Rule | Text | Char | $ | 100 | $100 | |
| EGROUP | Event Group | Text | Char | $ | 100 | $100 | |
| EVENT | Event | Text | Char | $ | 100 | $100 | |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 100 | $100 | |
| IGROUP | Item Group | Text | Char | $ | 100 | $100 | |
| IGSEQ | Item Group Sequence | Text | Char | $ | 100 | $100 | |
| ITEM | Item | Text | Char | $ | 100 | $100 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CREATEDB | Created By | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| USERMODDT | User Modified Date | Text | Char | $ | 100 | $100 | |
| USERMODB | User Modified By | Text | Char | $ | 100 | $100 | |
| INACBYSYS | Inactivated by System | Text | Char | $ | 100 | $100 | |
| LASTINACDT | Last Inactivated Date | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_RAND
The SYS_RAND dataset lists the following Randomization information, if Randomization is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITE | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| RANDSTATUS | Randomization Status | Text | Char | $ | 200 | $200 | |
| RANDID | Randomization ID | Text | Char | $ | 200 | $200 | |
| RANDSTRATA | Strata Group | Text | Char | $ | 200 | $200 | |
| RANDBY | Randomized By | Text | Char | $ | 200 | $200 | |
| RANDDAT | Randomized Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| RANDFILE | Randomization File Label | Text | Char | $ | 200 | $200 | |
| RANDFILEDAT | Randomization File Upload Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LABRANGES
The SYS_LABRANGES dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 100 | $100 | |
| LABLOC | Lab Location | Text | Char | $ | 200 | $200 | |
| LABANALYTENAME | Analyte Name | Text | Char | $ | 200 | $200 | |
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 200 | $200 | |
| LABREFRSTATUS | Lab Reference Range Status | Text | Char | $ | 20 | $20 | |
| LABTESTCODE | Test Code | Text | Char | $ | 200 | $200 | |
| LABSEX | Sex | Text | Char | $ | 20 | $20 | |
| LABLOWERAGE | Lower Age | Integer | Num | 14 | 8 | ||
| LABUPPERAGE | Upper Age | Integer | Num | 14 | 8 | ||
| LABAGEUNIT | Age Unit | Text | Char | $ | 100 | $100 | |
| LABFEMCYCLE | Female Cycle | Text | Char | $ | 100 | $100 | |
| LABLNORMAL | Lower Normal | Float | Num | 14 | 8 | ||
| LABUNORMAL | Upper Normal | Float | Num | 14 | 8 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 100 | $100 | |
| LABMEASUNITLABEL | Measurement Unit Label | Text | Char | $ | 100 | $100 | |
| LABCODENORM | Codelist Normal | Text | Char | $ | 100 | $100 | |
| LABTEXTNORM | Text Normal | Text | Char | $ | 100 | $100 | |
| LABMODIFIER | Lab Modifier | Text | Char | $ | 5 | 5 | |
| LABFROMDT | Effective From Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABTODT | Effective To Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABDESCR | Description | Text | Char | $ | 100 | $100 | |
| LABSPECTYPE | Specimen Type | Text | Char | $ | 100 | $100 | |
| LABTESTMET | Testing Method | Text | Char | $ | 100 | $100 | |
| CREATB | Created By | Text | Char | $ | 100 | $100 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LABLOC
The SYS_LABLOC dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 100 | $100 | |
| LABLOC | Lab Location | Text | Char | $ | 200 | $200 | |
| LABLOCSTATUS | Lab Location Status | Text | Char | $ | 100 | $100 | |
| LABAPPROVED | Approved Lab Location | Text | Char | $ | 100 | $100 | |
| LABADDRESS | Lab Address | Text | Char | $ | 200 | $200 | |
| LABCOUNTRY | Lab Country | Text | Char | $ | 200 | $200 | |
| LABCONTACT | Lab Contact Name | Text | Char | $ | 200 | $200 | |
| LABCONTITLE | Lab Contact Title | Text | Char | $ | 200 | $200 | |
| LABTEL | Lab Telephone | Text | Char | $ | 20 | $20 | |
| LABFAX | Lab Fax | Text | Char | $ | 100 | $100 | |
| LABPRIMEMAIL | Lab Primary Email | Text | Char | $ | 100 | $100 | |
| LABSECMAIL | Lab Secondary Email | Text | Char | $ | 100 | $100 | |
| LABSTATUS | Lab Status | Text | Char | $ | 100 | $100 | |
| CREATEDB | Created By | Text | Char | $ | 100 | $100 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ANALYTES
The SYS_ANALYTES dataset lists the following Labs analyte information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABANALYTENAME | Analyte Name | Text | Char | $ | 200 | $200 | |
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 200 | $200 | |
| LABDESCR | Description | Text | Char | $ | 1000 | $1000 | |
| LABDATATYPE | Data Type | Text | Char | $ | 200 | $200 | |
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 200 | $200 | |
| LABCODELIST | Codelist | Text | Char | $ | 200 | $200 | |
| LABMODIFIER | Lab Modifier | Text | Char | $ | 5 | 5 | |
| LABSPECTYPE | Specimen Type | Text | Char | $ | 200 | $200 | |
| LABLEN | Length | Integer | Num | 14 | 8 | ||
| LABPREC | Precision | Text | Char | $ | 200 | $200 | |
| LABSYSMANAGED | System Managed | Text | Char | $ | 5 | 5 | |
| LABTESTMET | Testing Method | Text | Char | $ | 200 | $200 | |
| LABLOINC | LOINC Code | Text | Char | $ | 200 | $200 | |
| LABSDTMNM | SDTM Name | Text | Char | $ | 1000 | $1000 | |
| CREATEDB | Created By | Text | Char | $ | 100 | $100 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
21R2 Version
Clinical Datasets
Each clinical dataset, and each Form (Adverse Events, Concomitant Medications, etc.), contains a set of Key Columns and a set of Clinical Data columns, which are detailed below.
Key Columns
Key Columns contain data to help identify which Form each row is referring to (ex: which Subject, Site, Cycle, or Event that particular form is located in).
The list of Key Columns is as follows:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITE | Site | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EGROUP | Event Group | Text | Char | $ | 200 | $200 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTID | Event External ID | Text | Char | $ | 100 | $100 | |
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| ESEQ | Event Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 200 | $200 | |
| FORMEID | Form External ID | Text | Char | $ | 100 | $100 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | ||
| DLASTMOD* | Datetime of Last Data Change (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| FGUID | Internal Vault ID (Forms) | Text | Char | $ | 200 | $200 | |
| IGGUID | Internal Vault ID (item groups) | Text | Char | $ | 1000 | $1000 | |
| FORMILB | Intentionally Left Blank | Boolean | Char | $ | 1 | $1 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LINKEDTO | Links to other forms | Text | Char | $ | 1500 | $1500 | |
| (ITEMNAME) | (Item Label) | Datetime | Num | $ | 14 | $200 | |
| (ITEMNAME)_UTC | (Item Label)_UTC | Datetime | Num | : vdatetime. | 14 | 8 | |
| (ITEMNAME)_USER | (Item Label)_USER | Datetime | Num | $ | 14 | $200 |
*Datetime columns can be separated into two separate Date and Time columns.
Coding Data
If a form is set up for coding, meaning that a coding configuration has been defined in Studio, coding-related columns will be added after clinical data columns. If there are multiple verbatims set up in a form, the system will add a set of coding columns for each verbatim configured. If the same item in different item groups is configured for coding, the system will add “itemgroup.item” to each column header to indicate which set of columns belongs to which verbatim.
List of coding columns for MedDRA:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 200 | $200 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 200 | $200 | |
| DICTVER | Dictionary Release | Text | Char | $ | 200 | $200 | |
| SOC | SOC | Text | Char | $ | 200 | $200 | |
| SOCID | SOC ID | Text | Char | $ | 200 | $200 | |
| HLGT | HLGT | Text | Char | $ | 200 | $200 | |
| HLGT ID | HLGT ID | Text | Char | $ | 200 | $200 | |
| HLT | HLT | Text | Char | $ | 200 | $200 | |
| HLT ID | HLT ID | Text | Char | $ | 200 | $200 | |
| PT | PT | Text | Char | $ | 200 | $200 | |
| PT ID | PT ID | Text | Char | $ | 200 | $200 | |
| LLT | LLT | Text | Char | $ | 200 | $200 | |
| LLT ID | LLT ID | Text | Char | $ | 200 | $200 | |
| PRIMPATH | Primary Path | Text | Char | $ | 200 | $200 | |
| LASTCODEDAT | Last Coded Date | Text | Char | $ | 200 | $200 | |
| LASTCODEBY | Last Coded By | Text | Char | $ | 200 | $200 |
List of coding columns for WHODrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| ATC1 | ATC1 | Text | Char | $ | 1500 | $6000 | |
| ATC1CD | ATC1 Code | Text | Char | $ | 1500 | $6000 | |
| ATC2 | ATC2 | Text | Char | $ | 1500 | $6000 | |
| ATC2CD | ATC2 Code | Text | Char | $ | 1500 | $6000 | |
| ATC3 | ATC3 | Text | Char | $ | 1500 | $6000 | |
| ATC3CD | ATC3 Code | Text | Char | $ | 1500 | $6000 | |
| ATC4 | ATC4 | Text | Char | $ | 1500 | $6000 | |
| ATC4CD | ATC4 Code | Text | Char | $ | 1500 | $6000 | |
| PREFNAME | Preferred Name | Text | Char | $ | 1500 | $6000 | |
| PREFCODE | Preferred Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| PREFBASE | Preferred Base Code | Text | Char | $ | 1500 | $6000 | |
| PREFLABEL | Preferred Base | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
List of coding columns for JDrug:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| CRSTATUS | Coding Status | Text | Char | $ | 100 | $400 | |
| DICTTYPE | Dictionary Type | Text | Char | $ | 100 | $400 | |
| DICTVER | Dictionary Release | Text | Char | $ | 128 | $512 | |
| DRUGCODE | Drug Code | Text | Char | $ | 1500 | $6000 | |
| DRUGNAME | Drug Name | Text | Char | $ | 1500 | $6000 | |
| GDRUGNAME | Generic Drug Name | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT1 | Drug Code Category 1 | Text | Char | $ | 1500 | $6000 | |
| DRUGCODECAT2 | Drug Code Category 2 | Text | Char | $ | 1500 | $6000 | |
| USECAT1 | Use Category 1 | Text | Char | $ | 1500 | $6000 | |
| USECAT2 | Use Category 2 | Text | Char | $ | 1500 | $6000 | |
| MANNAME | Manufacturer Name | Text | Char | $ | 1500 | $6000 | |
| MANCODE | Manufacturer Code | Text | Char | $ | 1500 | $6000 | |
| MAINTFLG | Maintenance Flag | Text | Char | $ | 1500 | $6000 | |
| MAINTDT | Maintenance Date | Text | Char | $ | 1500 | $6000 | |
| LASTCODEDAT | Last Coded Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTCODEDBY | Last Coded By | Text | Char | $ | 201 | $804 |
Definitions File
The Study Data Extract ZIP file contains a definition file, which is a listing of all columns across all datasets included in the extract.
List of columns included in the Definitions file:
| Column Header | Data |
|---|---|
| Dataset Name | Name of the dataset |
| Column | Name of the column |
| Type | Item type for clinical data items |
| SAS Type | SAS type of the column |
| SAS Informat | SAS informat applied |
| SAS Format | SAS format applied |
| Length | Length in characters |
| SAS Length | SAS length in bytes |
| Label | SAS Label of the column |
System Datasets
SYS_SITE
The SYS_SITE dataset lists all sites for the selected study.
List of SYS_SITE columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | 100 | |
| COUNTRY | Study Country | Text | Char | $ | 100 | 100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | 100 | |
| SITENAME | Study Site Name | Text | Char | $ | 100 | 100 | |
| INVNAME | Principal Investigator | Text | Char | $ | 100 | 100 | |
| CASEBDEF | Casebook Version | Integer | Char | $ | 100 | 100 | |
| STATUS | Site Status | Text | Char | $ | 100 | 100 | |
| TIMEZONE | Timezone of the Site | Text | Char | $ | 100 | 100 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | 100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_SUB
The SYS_SUB dataset lists all subjects for the selected study.
List of SYS_SUB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | 100 | |
| COUNTRY | Country | Text | Char | $ | 100 | 100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | 100 | |
| SUBJID | Subject | Text | Char | $ | 100 | 100 | |
| CASEBDEF | Casebook Version | Integer | Char | $ | 100 | 100 | |
| STATUS | Status of the Subject/Casebook | Text | Char | $ | 100 | 100 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | 100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| SCRDDT | Screened date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| SCRFAILDT | Screen failed date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| ENRDDT | Enrolled date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| RDMDDT | Randomized date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| ENDTRTDT | End of treatment date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| WTHDRWNDT | Withdrawn date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| CMPLTDT | End of study date | Date | Num | : vdate. | DATE9. | 14 | 9 |
SYS_EVT
The SYS_EVT dataset lists all events as well as event dates and status for the selected study.
List of SYS_EVT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTDT | Event Date | Date | Num | : vdate. | DATE9 | 14 | 8 |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | ||
| CASEBDEF | Casebook Version | Integer | Char | $ | 20 | $20 | |
| STATUS | Status of the event/visit | Text | Char | $ | 100 | $100 | |
| LASTREAS | Last change reason | Text | Char | $ | 200 | $200 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_FORM
The SYS_FORM dataset lists all forms for the selected study, including forms Intentionally Left Blank as well as review statuses, freeze and lock statuses, and additional metrics.
List of SYS_FORM columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTDT | Event date | Date | Num | : vdate. | DATE9. | 14 | 8 |
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 200 | $200 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| STATUS | Form Status | Text | Char | $ | 100 | $100 | |
| CREATEDT | Datetime form created | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| SUBMITDT | Datetime form last submitted | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| NSUBMITS | Number of times form was submitted | Integer | Num | 14 | 8 | ||
| SDVDT | Datetime considered SDV complete (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TOSDV | Days from submit to SDV | Float | Num | 14 | 8 | ||
| DMRDT | Datetime considered DMR complete | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| DMRLAST | Datetime of last DMR modification (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TODMR | Days from submit to DMR | Float | Num | 14 | 8 | ||
| FREEZEDT | Datetime frozen (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TOFREEZE | Days from submit to freeze | Float | Num | 14 | 8 | ||
| LOCKDT | Datetime locked (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TOLOCK | Days from submit to lock | Float | Num | 14 | 8 | ||
| SIGNDT | Datetime signed (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TOSIGN | Days from submit to sign | Integer | Num | 14 | 8 | ||
| EDT_SUBM | Days from event date (of form) to submit date | Float | Num | 14 | 8 | ||
| ILB | Intentionally Left Blank | Boolean | Char | $ | 100 | $100 | |
| ILBREAS | Reason for Intentionally Left Blank | Text | Char | $ | 200 | $200 | |
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_Q
The SYS_Q dataset lists all queries for the selected study, along with some query metrics. Only the first query message is listed in this dataset. The full list of query messages (first message, answers, etc.) is included in the SYS_QT dataset.
List of SYS_Q columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| ESEQ | Event Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 200 | $200 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| ITEMGROUP | Item group | Text | Char | $ | 200 | $200 | |
| IGSEQ | Item group sequence | Integer | Num | 14 | 8 | ||
| ITEM | Item | Text | Char | $ | 200 | $200 | |
| QUERYID | Query ID | Text | Char | $ | 200 | $200 | |
| STATUS | Query status | Text | Char | $ | 100 | $100 | |
| MANUAL | Manual query | Text | Char | $ | 200 | $200 | |
| RULEID | Rule name | Text | Char | $ | 200 | $200 | |
| TRIGID | Trigger name | Text | Char | $ | 200 | $200 | |
| QTEXT | Initial query text/message | Text | Char | $ | 200 | $200 | |
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CREATEDB | Created by | Text | Char | $ | 100 | $100 | |
| QUERYTEAM | Query team | Text | Char | $ | 100 | $100 | |
| QTFRESP | Time to first response (days) | Float | Num | 14 | 8 | ||
| QAGE | Query Age (days) | Float | Num | 14 | 8 | ||
| QOTOCL | Query open to close (days) | Float | Num | 14 | 8 | ||
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_QT
The SYS_QT dataset lists all query messages for the selected study.
You can link the content of this file with the SYS_Q dataset using the QUERYID column. There can be multiple SYS_QT records matching one SYS_Q record (i.e. a query in SYS_Q can have multiple query messages in SYS_QT).
List of SYS_QT columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| QUERYID | Query ID | Text | Char | $ | 200 | $200 | |
| STATUS | Query status | Text | Char | $ | 100 | $100 | |
| QTEXT | Initial query text/message | Text | Char | $ | 200 | $200 | |
| TEXTDT | Text/Message Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| TEXTBY | Text/Message By | Text | Char | $ | 100 | $100 | |
| QUERYTEAM | Query team | Text | Char | $ | 100 | $100 | |
| GUID | Internal Vault ID of the event | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ILB
The SYS_ILB dataset lists all items that have been marked Intentionally Left Blank in the selected study.
List of SYS_ILB columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITENUM | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| FORM | Form | Text | Char | $ | 200 | $200 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| IGROUP | Item Group | Text | Char | $ | 100 | $100 | |
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | ||
| ITEM | Item | Text | Char | $ | 200 | $200 | |
| DATASETNAME | Dataset name | Text | Char | $ | 100 | $100 | |
| ILBREAS | Reason for intentionally left blank | Text | Char | $ | 200 | $200 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LINKS
The SYS_LINKS dataset lists all forms that belong to a form link in the selected study. Forms that are linked together will share the same link ID, which will display in the GUID column. The form unique identifier (FGUID) can then be used to identify a specific form and access its data.
List of SYS_LINKS columns:
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 100 | $100 | |
| COUNTRY | Country | Text | Char | $ | 100 | $100 | |
| SITE | Study Site Number | Text | Char | $ | 100 | $100 | |
| SUBJID | Subject | Text | Char | $ | 100 | $100 | |
| EGROUP | Event group | Text | Char | $ | 200 | $200 | |
| EVENT | Event | Text | Char | $ | 200 | $200 | |
| EVENTEID | Event external ID | Text | Char | $ | 200 | $200 | |
| ESEQ | Event Sequence | Integer | Num | 14 | 8 | ||
| FORM | Form | Text | Char | $ | 20 | $20 | |
| FORMEID | Form external ID | Text | Char | $ | 20 | $20 | |
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | ||
| CREATED | Created date/time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| CREATEDB | Created by | Text | Char | $ | 100 | $100 | |
| FGUID | Internal vault ID (forms) | Text | Char | $ | 100 | $100 | |
| GUID | Internal Vault ID of the site | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | :vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASM
The SYS_ASM dataset lists the following information about assessments, if assessments are configured for a Study.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| SOURCEF | Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| SOURCEFEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| ASMNAME | Assessment Name | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| ASMEID | Assessment External ID | Text | Char | $ | 128 | $512 | ||
| ASMTYPE | Assessment Type | Text | Char | $ | 128 | $512 | ||
| REASSESSMENT | Reassessment | Boolean | Char | $ | 5 | $20 | ||
| SOURCEF | Source Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| STATUS | Status of Assessment | Text | Char | $ | 100 | $400 | ||
| SOURCEFRESTRICTED | Source Form Restricted | Boolean | Char | $ | 5 | $20 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| COMPDT | Completed Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| NSUBMITS | Submit Count | Integer | Num | 14 | 8 | |||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| GUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| FGUID | Internal Vault ID of the form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ASMR
The SYS_ASMR dataset lists questions and answers for all assessments in a Study, if assessments are configured.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | $ | 128 | $512 | ||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| SOURCEF | Form | Text | Char | $ | 128 | $512 | ||
| SOURCEFDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| SOURCEFEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| QUESNUM | Question Number | Integer | Num | 14 | 8 | |||
| ASMNAME | Assessment Name | Text | Char | $ | 128 | $512 | ||
| ASMLABEL | Assessment Label | Text | Char | $ | 128 | $512 | ||
| ASMEID | Assessment External ID | Text | Char | $ | 128 | $512 | ||
| QUESTEXT | Question Text | Text | Char | $ | 128 | $512 | ||
| QUESTEXTDEF | Question Text Definition | Text | Char | $ | 128 | $512 | ||
| QUESEID | Question External ID | Text | Char | $ | 128 | $512 | ||
| QUESANS | Question Answer | Text | Char | $ | 1500 | $6000 | ||
| SOURCEFRESTRICTED | Source Form Restricted | Boolean | Char | $ | 5 | $20 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| AGUID | Assessment Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_PD
The SYS_PD dataset lists the following Protocol Deviations information, if Protocol Deviations is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITENUM | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| PDID | Protocol Deviation Identifier | Text | Char | $ | 128 | $512 | ||
| PDSUM | Protocol Deviation Summary | Text | Char | $ | 250 | $1000 | ||
| PDDAT | Date of Deviation | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDDATID | Date Identified | Date | Num | : vdate. | DATE9. | 14 | 8 | |
| PDCAT | Category | Text | Char | $ | 128 | $512 | ||
| PDCATLABEL | Category Label | Text | Char | $ | 128 | $512 | ||
| PDSUBCAT | Subcategory | Text | Char | $ | 128 | $512 | ||
| PDSUBCATLABEL | Subcategory Label | Text | Char | $ | 128 | $512 | ||
| PDSEV | Severity | Text | Char | $ | 128 | $512 | ||
| PDSEVLABEL | Severity Label | Text | Char | $ | 128 | $512 | ||
| PDDESC | Description | Text | Char | $ | 500 | $2000 | ||
| PDSTATUS | Protocol Deviation Status | Text | Char | $ | 100 | $400 | ||
| PDRES | Protocol Deviation Resolution | Text | Char | $ | 500 | $2000 | ||
| PDRULE | Protocol Deviation Rule | Text | Char | $ | 128 | $512 | ||
| RESTRICTED | Protocol Deviation Restricted | Boolean | Char | 5 | $20 | |||
| EGROUP | Event Group | Text | Char | $ | 128 | $512 | ||
| EGROUPDEF | Event Group Definition | Text | Char | $ | 128 | $512 | ||
| EGROUPEID | Event Group External ID | Text | Char | 128 | $512 | |||
| EVENT | Event | Text | Char | $ | 128 | $512 | ||
| EVENTDEF | Event Definition | Text | Char | $ | 128 | $512 | ||
| EVENTEID | Event External ID | Text | Char | $ | 128 | $512 | ||
| ESEQ | Event Group Sequence | Integer | Num | 14 | 8 | |||
| FORM | Form | Text | Char | $ | 128 | $512 | ||
| FORMDEF | Form Definition | Text | Char | $ | 128 | $512 | ||
| FORMEID | Form External ID | Text | Char | $ | 128 | $512 | ||
| FSEQ | Form Sequence | Integer | Num | 14 | 8 | |||
| IGROUP | Item Group | Text | Char | $ | 500 | $2000 | ||
| IGROUPDEF | Item Group | Text | Char | $ | 128 | $512 | ||
| IGROUPEID | Item Group External ID | Text | Char | $ | 128 | $512 | ||
| IGSEQ | Item Group Sequence | Integer | Num | 14 | 8 | |||
| ITEM | Item | Text | Char | $ | 500 | $2000 | ||
| ITEMDEF | Item Definition | Text | Char | $ | 128 | $512 | ||
| ITEMEID | Item External ID | Text | Char | 128 | $512 | |||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| USERMODDT | User Modified Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| USERMODB | User Modified By | Text | Char | $ | 201 | $804 | ||
| LASTREAS | Last Change Reason | Text | Char | $ | 255 | $1020 | ||
| INACBYSYS | Inactivated by System | Boolean | Char | $ | 5 | $20 | ||
| LASTINACDT | Last Inactivated Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| FGUID | Internal Vault ID of Form | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| PDGUID | Internal Vault ID of Protocol Deviation | Text | Char | $ | 15 | $60 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_RAND
The SYS_RAND dataset lists the following Randomization information, if Randomization is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| STUDYID | Study | Text | Char | $ | 128 | $512 | ||
| COUNTRY | Country | Text | Char | $ | 128 | $512 | ||
| SITE | Study Site Number | Text | Char | $ | 128 | $512 | ||
| SUBJID | Subject | Text | Char | $ | 128 | $512 | ||
| RANDSTATUS | Randomization Status | Text | Char | $ | 100 | $400 | ||
| RANDID | Randomization ID | Text | Char | $ | 128 | $512 | ||
| TREATMENTNAME* | Treatment Name | Text | Char | $ | 128 | $512 | ||
| TREATMENTLABEL* | Treatment Label | Text | Char | $ | 1500 | $6000 | ||
| TREATMENTARM* | Treatment Arm | Text | Char | $ | 128 | $512 | Visible if "Include Randomization Treatment" is selected in SDE Version 22R1 or later | |
| RANDSTRATA | Strata Group | Text | Char | $ | 128 | $512 | ||
| RANDBY | Randomized By | Text | Char | $ | 201 | $804 | ||
| RANDDAT | Randomized Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| RANDFILE | Randomization File Label | Text | Char | $ | 128 | $512 | ||
| RANDFILEDAT | Randomization File Upload Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LABRANGES
The SYS_LABRANGES dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 100 | $100 | |
| LABLOC | Lab Location | Text | Char | $ | 200 | $200 | |
| LABANALYTENAME | Analyte Name | Text | Char | $ | 200 | $200 | |
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 200 | $200 | |
| LABREFRSTATUS | Lab Reference Range Status | Text | Char | $ | 20 | $20 | |
| LABTESTCODE | Test Code | Text | Char | $ | 200 | $200 | |
| LABSEX | Sex | Text | Char | $ | 20 | $20 | |
| LABLOWERAGE | Lower Age | Integer | Num | 14 | 8 | ||
| LABUPPERAGE | Upper Age | Integer | Num | 14 | 8 | ||
| LABAGEUNIT | Age Unit | Text | Char | $ | 100 | $100 | |
| LABFEMCYCLE | Female Cycle | Text | Char | $ | 100 | $100 | |
| LABLNORMAL | Lower Normal | Float | Num | 14 | 8 | ||
| LABUNORMAL | Upper Normal | Float | Num | 14 | 8 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 100 | $100 | |
| LABMEASUNITLABEL | Measurement Unit Label | Text | Char | $ | 100 | $100 | |
| LABCODENORM | Codelist Normal | Text | Char | $ | 100 | $100 | |
| LABTEXTNORM | Text Normal | Text | Char | $ | 100 | $100 | |
| LABMODIFIER | Lab Modifier | Text | Char | $ | 5 | 5 | |
| LABFROMDT | Effective From Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABTODT | Effective To Date | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LABDESCR | Description | Text | Char | $ | 100 | $100 | |
| LABSPECTYPE | Specimen Type | Text | Char | $ | 100 | $100 | |
| LABTESTMET | Testing Method | Text | Char | $ | 100 | $100 | |
| CREATB | Created By | Text | Char | $ | 100 | $100 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_LABLOC
The SYS_LABLOC dataset lists the following Labs information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length |
|---|---|---|---|---|---|---|---|
| LABID | Lab ID | Text | Char | $ | 100 | $100 | |
| LABLOC | Lab Location | Text | Char | $ | 100 | $100 | |
| LABLOCSTATUS | Lab Location Status | Text | Char | $ | 100 | $100 | |
| LABAPPROVED | Approved Lab Location | Text | Char | $ | 100 | $100 | |
| LABADDRESS | Lab Address | Text | Char | $ | 200 | $200 | |
| LABCOUNTRY | Lab Country | Text | Char | $ | 200 | $200 | |
| LABCONTACT | Lab Contact Name | Text | Char | $ | 200 | $200 | |
| LABCONTITLE | Lab Contact Title | Text | Char | $ | 200 | $200 | |
| LABTEL | Lab Telephone | Text | Char | $ | 20 | $20 | |
| LABFAX | Lab Fax | Text | Char | $ | 100 | $100 | |
| LABPRIMEMAIL | Lab Primary Email | Text | Char | $ | 100 | $100 | |
| LABSECMAIL | Lab Secondary Email | Text | Char | $ | 100 | $100 | |
| LABSTATUS | Lab Status | Text | Char | $ | 100 | $100 | |
| CREATEDB | Created By | Text | Char | $ | 100 | $100 | |
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| LASTMODB | Last Modified By | Text | Char | $ | 100 | $100 | |
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $100 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
SYS_ANALYTES
The SYS_ANALYTES dataset lists the following Labs analyte information, if Labs is enabled.
| Column Header | Label | Type | SAS Type | SAS Informat | SAS Format | Length | SAS Length | Notes |
|---|---|---|---|---|---|---|---|---|
| LABANALYTENAME | Analyte Name | Text | Char | $ | 128 | $512 | ||
| LABANALYTELABEL | Analyte Label | Text | Char | $ | 128 | $512 | ||
| LABDESCR | Description | Text | Char | $ | 500 | $2000 | ||
| LABDATATYPE | Data Type | Text | Char | $ | 100 | $400 | ||
| LABMEASUNIT | Measurement Unit | Text | Char | $ | 128 | $512 | ||
| LABCODELIST | Codelist | Text | Char | $ | 128 | $512 | ||
| LABMODIFIER | Lab Modifier | Boolean | Char | $ | 5 | $20 | ||
| LABSPECTYPE | Specimen Type | Text | Char | $ | 128 | $512 | ||
| LABLEN | Length | Integer | Num | 14 | 8 | |||
| LABPREC | Precision | Integer | Num | 14 | 8 | |||
| LABSYSMANAGED | System Managed | Boolean | Char | $ | 5 | $20 | ||
| LABTESTMET | Testing Method | Text | Char | $ | 128 | $512 | ||
| LABLOINC | LOINC Code | Text | Char | $ | 128 | $512 | ||
| LABSDTMNM | SDTM Name | Text | Char | $ | 255 | $1020 | ||
| CREATEDB | Created By | Text | Char | $ | 201 | $804 | ||
| CREATEDT | Created Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| LASTMODB | Last Modified By | Text | Char | $ | 201 | $804 | ||
| LASTMODDT | Last Modified Date/Time (UTC) | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 | |
| GUID | Internal Vault ID | Text | Char | $ | 100 | $400 | For HVO objects, the Length is 15, SAS Length is 60 | |
| LASTRUN | Last run of this data/listing | Datetime | Num | : vdatetime. | DATETIME22.3 | 14 | 8 |
For more information about the Study Data Extract job, please refer to the SDE help page.