Study Data Extracts Versioning

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

Jobs scheduled prior to the 22R1 release will be stamped with the 21R3 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.

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

*Datetime columns can be separated into two separate Date and Time columns.

Coding Data

If a form is set up for coding, meaning that a coding configuration has been defined in Studio, coding-related columns will be added after clinical data columns. If there are multiple verbatims set up in a form, the system will add a set of coding columns for each verbatim configured. If the same item in different item groups is configured for coding, the system will add “itemgroup.item” to each column header to indicate which set of columns belongs to which verbatim.

List of coding columns for MedDRA:

Column Header	Label	Type	SAS Type	SAS Informat	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
LATESTARM	Latest Arm	Text	Char	$		100	100
LATESTCOHORT	Latest Cohort	Text	Char	$		100	100
LATESTSUBSTUDY	Latest Substudy	Text	Char	$		100	100
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

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

SYS_EVT

The SYS_EVT dataset lists all events as well as event dates and status for the selected study.

List of SYS_EVT columns:

Column Header	Label	Type	SAS Type	SAS Informat	SAS Format	Length	SAS Length
STUDYID	Study	Text	Char	$		100	$100
COUNTRY	Country	Text	Char	$		100	$100
SITENUM	Study Site Number	Text	Char	$		100	$100
SUBJID	Subject	Text	Char	$		100	$100
EGROUP	Event Group	Text	Char	$		200	$200
EVENT	Event	Text	Char	$		200	$200
EVENTEID	Event External ID	Text	Char	$		200	$200
EVENTDT	Event Date	Date	Num	: vdate.	DATE9	14	8
ESEQ	Event Group Sequence	Integer	Num			14	8
LASTMODDT	Last modified date/time of the event date (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
CASEBDEF	Casebook Version	Integer	Char	$		20	$20
STATUS	Status of the event/visit	Text	Char	$		100	$100
LASTREAS	Last change reason	Text	Char	$		200	$200
WINSTAT	Scheduled Window Status	Text	Char	$		100	$100
DAYSOW	Days Outside Window	Integer	Num			14	8
EXPFORMS	Expected Number of Forms	Integer	Num			14	8
FORMEOD	Number of days past due when one or more forms is not yet complete	Integer	Num			14	8
GUID	Internal Vault ID of the site	Text	Char	$		100	$100
LASTRUN	Last run of this data/listing	Datetime	Num	: vdatetime.	DATETIME22.3	14	8

SYS_FORM

The SYS_FORM dataset lists all forms for the selected study, including forms Intentionally Left Blank as well as review statuses, freeze and lock statuses, and additional metrics.

List of SYS_FORM columns:

Column Header	Label	Type	SAS Type	SAS Informat	SAS Format	Length	SAS Length
STUDYID	Study	Text	Char	$		100	$100
COUNTRY	Country	Text	Char	$		100	$100
SITENUM	Study Site Number	Text	Char	$		100	$100
SUBJID	Subject	Text	Char	$		100	$100
EGROUP	Event Group	Text	Char	$		200	$200
EVENT	Event	Text	Char	$		200	$200
EVENTEID	Event External Id	Text	Char	$		200	$200
EVENTDT	Event date	Date	Num	: vdate.	DATE9.	14	8
ESEQ	Event Group Sequence	Integer	Num			14	8
FORM	Form	Text	Char	$		200	$200
FORMEID	Form External ID	Text	Char	$		100	$100
FSEQ	Form Sequence	Integer	Num			14	8
STATUS	Form Status	Text	Char	$		100	$100
CREATEDT	Datetime form created	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
SUBMITDT	Datetime form last submitted	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
NSUBMITS	Number of times form was submitted	Integer	Num			14	8
SDVREQ	SDV Required	Boolean	Char	$		1	$1
SDVDT	Datetime considered SDV complete (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
SDVLAST	Datetime of last SDV modification (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
TOSDV	Days from submit to SDV	Float	Num			14	8
DMRREQ	DMR Required	Boolean	Char	$		1	$1
DMRDT	Datetime considered DMR complete	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
DMRLAST	Datetime of last DMR modification (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
TODMR	Days from submit to DMR	Float	Num			14	8
FREEZEDT	Datetime frozen (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
TOFREEZE	Days from submit to freeze	Float	Num			14	8
LOCKDT	Datetime locked (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
TOLOCK	Days from submit to lock	Float	Num			14	8
SIGNDT	Datetime signed (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
LSTSGNDT	Last Signature Date	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
TOSIGN	Days from submit to sign	Integer	Num			14	8
EDT_SUBM	Days from event date (of form) to submit date	Float	Num			14	8
ILB	Intentionally Left Blank	Boolean	Char	$		100	$100
ILBREAS	Reason for Intentionally Left Blank	Text	Char	$		200	$200
GUID	Internal Vault ID of the event	Text	Char	$		100	$100
LASTRUN	Last run of this data/listing	Datetime	Num	: vdatetime.	DATETIME22.3	14	8

SYS_Q

The SYS_Q dataset lists all queries for the selected study, along with some query metrics. Only the first query message is listed in this dataset. The full list of query messages (first message, answers, etc.) is included in the SYS_QT dataset.

List of SYS_Q columns:

Column Header	Label	Type	SAS Type	SAS Informat	SAS Format	Length	SAS Length
STUDYID	Study	Text	Char	$		100	$100
COUNTRY	Country	Text	Char	$		100	$100
SITENUM	Study Site Number	Text	Char	$		100	$100
SUBJID	Subject	Text	Char	$		100	$100
EGROUP	Event Group	Text	Char	$		200	$200
EVENT	Event	Text	Char	$		200	$200
EVENTEID	Event External Id	Text	Char	$		200	$200
ESEQ	Event Group Sequence	Integer	Num			14	8
FORM	Form	Text	Char	$		200	$200
FORMEID	Form External ID	Text	Char	$		100	$100
FSEQ	Form Sequence	Integer	Num			14	8
ITEMGROUP	Item group	Text	Char	$		200	$200
IGSEQ	Item group sequence	Integer	Num			14	8
ITEM	Item	Text	Char	$		200	$200
QUERYID	Query ID	Text	Char	$		200	$200
STATUS	Query status	Text	Char	$		100	$100
MANUAL	Manual query	Text	Char	$		200	$200
RULEID	Rule name	Text	Char	$		200	$200
TRIGID	Trigger name	Text	Char	$		200	$200
QTEXT	Initial query text/message	Text	Char	$		200	$200
CREATED	Created date/time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
CREATEDB	Created by	Text	Char	$		100	$100
QUERYTEAM	Query team	Text	Char	$		100	$100
QTFRESP	Time to first response (days)	Float	Num			14	8
QAGE	Query Age (days)	Float	Num			14	8
QCHGDATA	Whether the data changed after query creation (field query attached)	Boolean	Char	$		1	$1
QOTOCL	Query open to close (days)	Float	Num			14	8
GUID	Internal Vault ID of the event	Text	Char	$		100	$100
LASTRUN	Last run of this data/listing	Datetime	Num	: vdatetime.	DATETIME22.3	14	8

SYS_QT

The SYS_QT dataset lists all query messages for the selected study.

You can link the content of this file with the SYS_Q dataset using the QUERYID column. There can be multiple SYS_QT records matching one SYS_Q record (i.e. a query in SYS_Q can have multiple query messages in SYS_QT).

List of SYS_QT columns:

Column Header	Label	Type	SAS Type	SAS Informat	SAS Format	Length	SAS Length
STUDYID	Study	Text	Char	$		100	$100
COUNTRY	Country	Text	Char	$		100	$100
SITENUM	Study Site Number	Text	Char	$		100	$100
SUBJID	Subject	Text	Char	$		100	$100
QUERYID	Query ID	Text	Char	$		200	$200
STATUS	Query status	Text	Char	$		100	$100
QTEXT	Initial query text/message	Text	Char	$		200	$200
TEXTDT	Text/Message Date/Time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
TEXTBY	Text/Message By	Text	Char	$		100	$100
QUERYTEAM	Query team	Text	Char	$		100	$100
GUID	Internal Vault ID of the event	Text	Char	$		100	$100
LASTRUN	Last run of this data/listing	Datetime	Num	: vdatetime.	DATETIME22.3	14	8

SYS_ILB

The SYS_ILB dataset lists all items that have been marked Intentionally Left Blank in the selected study.

List of SYS_ILB columns:

Column Header	Label	Type	SAS Type	SAS Informat	SAS Format	Length	SAS Length
STUDYID	Study	Text	Char	$		100	$100
COUNTRY	Country	Text	Char	$		100	$100
SITENUM	Study Site Number	Text	Char	$		100	$100
SUBJID	Subject	Text	Char	$		100	$100
EGROUP	Event Group	Text	Char	$		200	$200
EVENT	Event	Text	Char	$		200	$200
EVENTEID	Event External Id	Text	Char	$		200	$200
ESEQ	Event Group Sequence	Integer	Num			14	8
FORM	Form	Text	Char	$		200	$200
FORMEID	Form External ID	Text	Char	$		100	$100
FSEQ	Form Sequence	Integer	Num			14	8
IGROUP	Item Group	Text	Char	$		100	$100
IGSEQ	Item Group Sequence	Integer	Num			14	8
ITEM	Item	Text	Char	$		200	$200
ITEMDEF	Item Definition	Text	Char	$		200	$200
LABANALYTENAME	Analyte Name	Text	Char	$		200	$200
DATASETNAME	Dataset name	Text	Char	$		100	$100
ILBREAS	Reason for intentionally left blank	Text	Char	$		200	$200
GUID	Internal Vault ID of the site	Text	Char	$		100	$100
LASTRUN	Last run of this data/listing	Datetime	Num	: vdatetime.	DATETIME22.3	14	8

SYS_LINKS

The SYS_LINKS dataset lists all forms that belong to a form link in the selected study. Forms that are linked together will share the same link ID, which will display in the GUID column. The form unique identifier (FGUID) can then be used to identify a specific form and access its data.

List of SYS_LINKS columns:

Column Header	Label	Type	SAS Type	SAS Informat	SAS Format	Length	SAS Length
STUDYID	Study	Text	Char	$		100	$100
COUNTRY	Country	Text	Char	$		100	$100
SITE	Study Site Number	Text	Char	$		100	$100
SUBJID	Subject	Text	Char	$		100	$100
EGROUP	Event group	Text	Char	$		200	$200
EVENT	Event	Text	Char	$		200	$200
EVENTEID	Event external ID	Text	Char	$		200	$200
ESEQ	Event Sequence	Integer	Num			14	8
FORM	Form	Text	Char	$		20	$20
FORMEID	Form external ID	Text	Char	$		20	$20
FSEQ	Form Sequence	Integer	Num			14	8
CREATED	Created date/time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
CREATEDB	Created by	Text	Char	$		100	$100
FGUID	Internal vault ID (forms)	Text	Char	$		100	$100
GUID	Internal Vault ID of the site	Text	Char	$		100	$100
LASTRUN	Last run of this data/listing	Datetime	Num	:vdatetime.	DATETIME22.3	14	8

SYS_ASM

The SYS_ASM dataset lists the following information about assessments, if assessments are configured for a Study.

Column Header	Label	Type	SAS Type	SAS Informat	SAS Format	Length	SAS Length
STUDYID	Study	Text	Char	$		100	$100
COUNTRY	Country	Text	Char	$		100	$100
SITENUM	Study Site Number	Text	Char	$		100	$100
SUBJID	Subject	Text	Char	$		100	$100
ASMNAME	Assessment Name	Text	Char	$		200	$200
ASMLABEL	Assessment Label	Text	Char	$		200	$200
ASMTYPE	Assessment Type	Text	Char	$		200	$200
SOURCEF	Source Form	Text	Char	$		200	$200
STATUS	Status of Assessment	Text	Char	$		200	$200
CREATEDT	Created Date/Time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
COMPDT	Completed Date/Time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
NSUBMITS	Submit Count	Text	Char	$		100	$100
LASTMODDT	Last Modified Date/Time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
LASTMODB	Last Modified By	Text	Char	$		100	$100
GUID	Assessment Vault ID	Text	Char	$		100	$100
FGUID	Source Form Vault ID	Text	Char	$		100	$100
LASTRUN	Last run of this data/listing	Datetime	Num	: vdatetime.	DATETIME22.3	14	8

SYS_ASMR

The SYS_ASMR dataset lists questions and answers for all assessments in a Study, if assessments are configured.

Column Header	Label	Type	SAS Type	SAS Informat	SAS Format	Length	SAS Length
STUDYID	Study	Text	Char	$		100	$100
COUNTRY	Country	Text	Char	$		100	$100
SITENUM	Study Site Number	Text	Char	$		100	$100
SUBJID	Subject	Text	Char	$		100	$100
ASMLABEL	Assessment Label	Text	Char	$		200	$200
QUESTEXT	Question Text	Text	Char	$		200	$200
QUESANS	Question Answer	Text	Char	$		200	$200
CREATEDT	Created Date/Time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
LASTMODDT	Last Modified Date/Time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
LASTMODB	Last Modified By	Text	Char	$		100	$100
AGUID	Assessment Vault ID	Text	Char	$		100	$100
LASTRUN	Last run of this data/listing	Datetime	Num	: vdatetime.	DATETIME22.3	14	8

SYS_PD

The SYS_PD dataset lists the following Protocol Deviations information, if Protocol Deviations is enabled.

Column Header	Label	Type	SAS Type	SAS Informat	SAS Format	Length	SAS Length
STUDYID	Study	Text	Char	$		100	$100
COUNTRY	Country	Text	Char	$		100	$100
SITENUM	Study Site Number	Text	Char	$		100	$100
SUBJID	Subject	Text	Char	$		100	$100
PDID	Protocol Deviation Identifier	Text	Char	$		200	$200
PDSUM	Protocol Deviation Summary	Text	Char	$		1000	$1000
PDDAT	Date of Deviation	Date	Num	: vdate.	DATE9.	14	8
PDDATID	Date Identified	Date	Num	: vdate.	DATE9.	14	8
PDCAT	Category	Text	Char	$		100	$100
PDSUBCAT	Subcategory	Text	Char	$		100	$100
PDSEV	Severity	Text	Char	$		100	$100
PDDESC	Description	Text	Char	$		1000	$1000
PDSTATUS	Protocol Deviation Status	Text	Char	$		100	$100
PDRES	Protocol Deviation Resolution	Text	Char	$		100	$100
PDRULE	Protocol Deviation Rule	Text	Char	$		100	$100
EGROUP	Event Group	Text	Char	$		100	$100
EVENT	Event	Text	Char	$		100	$100
ESEQ	Event Group Sequence	Integer	Num			14	8
FORM	Form	Text	Char	$		100	$100
IGROUP	Item Group	Text	Char	$		100	$100
IGSEQ	Item Group Sequence	Text	Char	$		100	$100
ITEM	Item	Text	Char	$		100	$100
CREATEDT	Created Date/Time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
CREATEDB	Created By	Text	Char	$		100	$100
LASTMODDT	Last Modified Date/Time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
USERMODDT	User Modified Date	Text	Char	$		100	$100
USERMODB	User Modified By	Text	Char	$		100	$100
INACBYSYS	Inactivated by System	Text	Char	$		100	$100
LASTINACDT	Last Inactivated Date	Text	Char	$		100	$100
LASTRUN	Last run of this data/listing	Datetime	Num	: vdatetime.	DATETIME22.3	14	8

SYS_RAND

The SYS_RAND dataset lists the following Randomization information, if Randomization is enabled.

Column Header	Label	Type	SAS Type	SAS Informat	SAS Format	Length	SAS Length
STUDYID	Study	Text	Char	$		100	$100
COUNTRY	Country	Text	Char	$		100	$100
SITE	Study Site Number	Text	Char	$		100	$100
SUBJID	Subject	Text	Char	$		100	$100
RANDSTATUS	Randomization Status	Text	Char	$		200	$200
RANDID	Randomization ID	Text	Char	$		200	$200
RANDSTRATA	Strata Group	Text	Char	$		200	$200
RANDBY	Randomized By	Text	Char	$		200	$200
RANDDAT	Randomized Date	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
RANDFILE	Randomization File Label	Text	Char	$		200	$200
RANDFILEDAT	Randomization File Upload Date	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
LASTRUN	Last run of this data/listing	Datetime	Num	: vdatetime.	DATETIME22.3	14	8

SYS_LABRANGES

The SYS_LABRANGES dataset lists the following Labs information, if Labs is enabled.

Column Header	Label	Type	SAS Type	SAS Informat	SAS Format	Length	SAS Length
LABID	Lab ID	Text	Char	$		100	$100
LABLOC	Lab Location	Text	Char	$		200	$200
LABANALYTENAME	Analyte Name	Text	Char	$		200	$200
LABANALYTELABEL	Analyte Label	Text	Char	$		200	$200
LABREFRSTATUS	Lab Reference Range Status	Text	Char	$		20	$20
LABTESTCODE	Test Code	Text	Char	$		200	$200
LABSEX	Sex	Text	Char	$		20	$20
LABLOWERAGE	Lower Age	Integer	Num			14	8
LABUPPERAGE	Upper Age	Integer	Num			14	8
LABAGEUNIT	Age Unit	Text	Char	$		100	$100
LABFEMCYCLE	Female Cycle	Text	Char	$		100	$100
LABLNORMAL	Lower Normal	Float	Num			14	8
LABUNORMAL	Upper Normal	Float	Num			14	8
LABMEASUNIT	Measurement Unit	Text	Char	$		100	$100
LABMEASUNITLABEL	Measurement Unit Label	Text	Char	$		100	$100
LABCODENORM	Codelist Normal	Text	Char	$		100	$100
LABTEXTNORM	Text Normal	Text	Char	$		100	$100
LABMODIFIER	Lab Modifier	Text	Char	$		5	5
LABFROMDT	Effective From Date	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
LABTODT	Effective To Date	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
LABDESCR	Description	Text	Char	$		100	$100
LABSPECTYPE	Specimen Type	Text	Char	$		100	$100
LABTESTMET	Testing Method	Text	Char	$		100	$100
CREATB	Created By	Text	Char	$		100	$100
CREATEDT	Created Date/Time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
LASTMODB	Last Modified By	Text	Char	$		100	$100
LASTMODDT	Last Modified Date/Time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
LASTRUN	Last run of this data/listing	Datetime	Num	: vdatetime.	DATETIME22.3	14	8

SYS_LABLOC

The SYS_LABLOC dataset lists the following Labs information, if Labs is enabled.

Column Header	Label	Type	SAS Type	SAS Informat	SAS Format	Length	SAS Length
LABID	Lab ID	Text	Char	$		100	$100
LABLOC	Lab Location	Text	Char	$		200	$200
LABLOCSTATUS	Lab Location Status	Text	Char	$		100	$100
LABAPPROVED	Approved Lab Location	Text	Char	$		100	$100
LABADDRESS	Lab Address	Text	Char	$		200	$200
LABCOUNTRY	Lab Country	Text	Char	$		200	$200
LABCONTACT	Lab Contact Name	Text	Char	$		200	$200
LABCONTITLE	Lab Contact Title	Text	Char	$		200	$200
LABTEL	Lab Telephone	Text	Char	$		20	$20
LABFAX	Lab Fax	Text	Char	$		100	$100
LABPRIMEMAIL	Lab Primary Email	Text	Char	$		100	$100
LABSECMAIL	Lab Secondary Email	Text	Char	$		100	$100
LABSTATUS	Lab Status	Text	Char	$		100	$100
CREATEDB	Created By	Text	Char	$		100	$100
CREATEDT	Created Date/Time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
LASTMODB	Last Modified By	Text	Char	$		100	$100
LASTMODDT	Last Modified Date/Time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
GUID	Internal Vault ID	Text	Char	$		100	$100
LASTRUN	Last run of this data/listing	Datetime	Num	: vdatetime.	DATETIME22.3	14	8

SYS_ANALYTES

The SYS_ANALYTES dataset lists the following Labs analyte information, if Labs is enabled.

Column Header	Label	Type	SAS Type	SAS Informat	SAS Format	Length	SAS Length
LABANALYTENAME	Analyte Name	Text	Char	$		200	$200
LABANALYTELABEL	Analyte Label	Text	Char	$		200	$200
LABDESCR	Description	Text	Char	$		1000	$1000
LABDATATYPE	Data Type	Text	Char	$		200	$200
LABMEASUNIT	Measurement Unit	Text	Char	$		200	$200
LABCODELIST	Codelist	Text	Char	$		200	$200
LABMODIFIER	Lab Modifier	Text	Char	$		5	5
LABSPECTYPE	Specimen Type	Text	Char	$		200	$200
LABLEN	Length	Integer	Num			14	8
LABPREC	Precision	Text	Char	$		200	$200
LABSYSMANAGED	System Managed	Text	Char	$		5	5
LABTESTMET	Testing Method	Text	Char	$		200	$200
LABLOINC	LOINC Code	Text	Char	$		200	$200
LABSDTMNM	SDTM Name	Text	Char	$		1000	$1000
CREATEDB	Created By	Text	Char	$		100	$100
CREATEDT	Created Date/Time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
LASTMODB	Last Modified By	Text	Char	$		100	$100
LASTMODDT	Last Modified Date/Time (UTC)	Datetime	Num	: vdatetime.	DATETIME22.3	14	8
GUID	Internal Vault ID	Text	Char	$		100	$100
LASTRUN	Last run of this data/listing	Datetime	Num	: vdatetime.	DATETIME22.3	14	8

21R2 Version