Study Data Extracts Versioning

23R1 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 (23R2) can be found here. Columns included in the previous versions (23R1, 22R3, 22R2, 22R1, 21R3, 21R2) are detailed below.

Jobs scheduled prior to the 23R2 release will be stamped with the 23R1 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.

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
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
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:

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
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	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
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
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
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
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
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, Closed, and Resolved 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
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
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
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
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
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
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
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
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
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

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
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.

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.

Coding Data

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

SYS_Q

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, 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
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.

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
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

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
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
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
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
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	$		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

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

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

List of coding columns for MedDRA:

Column Header	Label	Type	SAS Type	SAS Informat	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	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	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

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, Closed, and Resolved 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.

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, Resolved, 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

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

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.

Coding Data

List of coding columns for MedDRA:

Column Header	Label	Type	SAS Type	SAS Informat	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	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	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

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.

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

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

List of coding columns for MedDRA:

Column Header	Label	Type	SAS Type	SAS Informat	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	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	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

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.

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

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

List of coding columns for MedDRA:

Column Header	Label	Type	SAS Type	SAS Informat	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

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.

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

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	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
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
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
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
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
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
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
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

For more information about the Study Data Extract job, please refer to the SDE help page.