Study Data Extracts

23R1 Version

The Study Data Extract job allows data managers to extract and download study execution data from EDC Tools. You can choose to download your data as a CSV or SAS file before running the job. Note that the encoding for CSVs and SAS is UTF-8, so it is recommended that you set your encoding to UTF-8 when viewing the export. This page shows SDE columns for the current release. To view columns from previous versions, see SDE Versioning.

Special Characters: If a study name has special characters, those characters will be changed to underscores when downloaded as an SAS file. If a dataset name begins with a number, Vault will add an underscore to the beginning of the file name for that dataset when downloaded as an SAS file.

Repeating Item Groups: Vault adds a row of data for each repeating Item Group. Rows are distinguished by their Item Group Sequence.

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
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
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
IGGUID Internal Vault ID (item groups) Text Char $ 100 $400
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:

  1. Codelists are split into two columns:
    • ITEMNAME: this column contains the codelist code
    • ITEMNAME_D: this column contains the codelist decode or label
  2. 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
  3. 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

Booleans: Boolean items always have either a Y (true) or N (false/null) value.

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
IGGUID Internal Vault ID (Item Groups) Text Char $ 15 $60 Length is 15 and SAS Lengh is 60 for HVO objects.
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 Text Char $ 1500 $6000 Normal Range Lower and Upper Limit_TRANSU
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
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
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 $ 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
LASTRUN Last run of this data/listing Datetime Num : vdatetime. DATETIME22.3 14 8
CNSNTDT Initial Consent Date Date Num : vdate. DATE9. 14 8
LATESTARM Latest Arm Text Char $ 128 $512
LATESTCOHORT Latest Cohort Text Char $ 128 $512
LATESTSUBSTUDY 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

Please note that the LATESTARM, LATESTCOHORT, and LATESTSUBSTUDY columns will only display if you have Arms & Cohorts enabled.

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 $ 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
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
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
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
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
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
QUERYID Query ID Text Char $ 128 $512
STATUS Query status Text Char $ 100 $400 Includes Open, Answered, Closed, and Resolved 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
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
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, Resolved, 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
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
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
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

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
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
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
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
SOURCEFDEF Form Definition 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
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
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
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
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
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
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
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
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
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 $ 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
LASTRUN Last run of this data/listing Datetime Num : vdatetime. DATETIME22.3 14 8

Form, Event, & Query Status

Below are statuses and their descriptions for forms, events, and queries.

Form Status

Status Description
Blank The Form has not been submitted and has no queries, no autosaves, and no fields left blank.
In Progress The Form has either not been submitted since the last data change or there are tasks that have not been completed on the Form.
Submitted The Form has been submitted and there are no open tasks.
In Progress Post-Submit During a retrospective casebook amendment, there is an option to set the form status to In Progress for any modified forms.

Event Status

Status Description
Planned The Event has no Actual Start Date or is scheduled in the future.
Blank The Event has an Actual Start Date, but all forms are in the Planned status.
In Progress The Event has an Actual Start Date and at least one form is not Submitted or has at least one task. This status can also indicate that at least one but not all Forms in the Event are frozen or locked.
Submitted All Forms in the Event are submitted and no forms have a Planned or Blank status.
Did Not Occur The Event did not occur during study conduct.

Query Status

Status Description
Open "Open" indicates that a query has not been answered.
Answered "Answered" indicates that a query has been addressed. For example, the site has responded with a reason for the queried value.
Closed "Closed" indicates that a query requires no further action or discussion. A CRA or Data Manager can reopen a closed query if needed.

SAS Format

If you select SAS as the Export File Format when scheduling your Study Data Extract job, the generated ZIP file contains two additional folders:

  • SAS: Contains sas7bdat files for each dataset
  • XPT: Contains XPT files for each dataset

Key columns use fixed conversions to either num or char SAS types, whereas clinical data columns are converted to a specific SAS type based on the item data type in EDC.

SAS validations and formatting:

  • Column names are limited to 32 characters. The system will truncate as necessary to append special suffixes like _TRANSU or _D.
  • SAS labels are limited to 255 characters. Labels that exceed 250 characters are truncated and have an ellipsis (…) added to the label.
  • ZIP file names are limited to 200 characters.
  • If a dataset starts with a number, it will be prefixed with an underscore (_).
  • If a clinical dataset has the same name as one of the system datasets, it will be appended with “_X” (X being a number that can be incremented).
  • If a column header starts with a number, it will be prefixed with an underscore (_).
  • If a value is entered with carriage returns (new line), these characters are replaced with spaces.
  • If the same column header is present multiple times (same item used in multiple item groups in the same form), the system appends “_X” (X being a number that can be incremented) to the column header. For column headers that already have a suffix (e.g. _TRANS), the “_X” suffix will be appended after the special suffix is added (_TRANS_2).

To view column names (instead of SAS labels) in the SAS viewer, right click and select Display Labels.

Note that SDE versions 22R1 and later will automatically compress SAS zip files.

FTP Connection

To configure an FTP connection, see Connecting to an FTP Server from EDC Tools.

Custom Objects

You can include custom objects in your exports by adding records to the Study Data Extract Custom Object Config object in Business Administration where you must specify the Name of the record, custom object name (objectname__c), and the Study that you’re going to run the SDE for.

Once you’ve configured a custom object and run the SDE job, you will receive a file named CUSTOM_.csv, which will have records for each custom object you configured.

The order of the columns in the custom object file follows the Page Layout configuration, with the exception of the GUID of the object always appearing at the beginning of the file.

Duplicate column names are appended with an _2, _3, etc. to prevent column name conflicts.

Note that custom object records must be unique within a study.

List of Custom Objects columns:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length Notes
GUID ID Text Char $ 100 $400
NAME Name Text Char $ 128 $512
STATUS Status Text Char $ 100 $400
CREATEDB Created By Text Char $ 201 $804
CREATED Created Date Datetime Num : vdatetime. DATETIME22.3 14 8
MODIFIEDB Modified By Text Char $ 201 $804
DLASTMOD Last Modified Date Datetime Num : vdatetime. DATETIME22.3 14 8
OBJECT_TYPE Object Type Text Char $ 40 $160 Visible if Object Types are enabled for Custom Objects

Running the Study Data Extract Job

To run the Study Data Extract job:

  1. Navigate to your Study in Tools > EDC Tools.
  2. Click Jobs.
  3. Click + New Job.
  4. Select Study Data Extract for Type. Study Data Extract new job

  5. Optional: Select Include Restricted Data to include data from restricted Forms in your extract.
  6. Optional: Select Include Randomization Treatment to include Randomization treatment information in the SYS_RAND dataset.
  7. Select which version of the SDE you’d like to run. Each job version determines which files are included in the extract and which version of the CSVs must be used. Note that the default version selected will be the latest version that is supported in the current release. See SDE Versioning for details.
  8. Optional: Make your selections for Clinical Data Options to determine how Vault handles clinical data formatting.
  9. Optional: Select which datasets to export. All System Datasets and Clinical Datasets will be selected by default. To specify which datasets to export, uncheck the Export All checkbox. Study Data Extract Data to Export Section

  10. Optional: Enter a ZIP File Name. This name is the filename that Vault will use for the generated ZIP file.
  11. Select an Export File Type.
  12. Optional (only 22R3 Version): Select Include Study Design to include a Definitions folder containing study design information in your extract. See below for more information on the Include Study Design option.
  13. Optional: Select an External Connection to receive the output file. Otherwise, Vault will send you a link to download the output when the job finishes.
  14. Optional: Configure a Frequency to run the job on a recurring basis. Learn more about scheduled jobs.
  15. Click Run Now.

Include Study Design (Version 22R3 and later)

The following files will be included in the Definitions folder when the Include Study Design option is checked:

  • Export Options: Includes all export options saved in the job record
  • Casebook Definitions: Includes all casebook versions
  • Casebook Schedule: Includes all casebook versions
  • Casebook Definition Summary: Includes information about the relationships between the Event Group, Event, Form, Item Group, and Items
  • Event Definitions: Includes information about Events and Event Groups
  • Event Group Repeat Overrides: Includes information about repeating Event Groups, if applicable
  • Form Definitions: Includes information about Forms
  • Item Definitions: Includes information about Items and Item Groups
  • Codelists: Includes Codelist information
  • Unit Codelists: Includes Unit Codelist information
  • Protocol Deviations: Includes information about Protocol Deviations, if applicable
  • Protocol Deviations Relationships: Includes information about Protocol Deviations relationships, if applicable
  • Medical Coding Items: Shows all medical coding items configured for a coding form, if applicable
  • Medical Coding Related Items: Shows optionally configured related items on a coding form, if applicable
  • Medical Coding Copy Indication from Links: Shows Form Links configured for Indication-related Item Types, if applicable

Note that the contents of the Casebook Schedule and Casebook Definition Summary files won’t appear in the order configured in Studio.

Troubleshooting

If extract jobs such as the Study Data Extract, Study Listings, or Detail PDF fail after removing or moving data from the study schedule in your DEV or UAT environments, try deleting the casebook data before retrying the jobs. Deleting data such as Event Groups, Forms, Item Groups, and Items from the study schedule while it is still in the design process is not supported by EDC and will cause exports to fail.

To avoid extract jobs failing, keep an eye on the following changes that may cause extract job failure:

Changes in the Study Schedule:

  • Removal of Event Groups, Events, Forms, Item groups, and Items

Changes in Business Admin

  • Modification of object records relating to Events, Forms, Item Groups, and Items