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

Jobs scheduled prior to the 22R2 release will be stamped with the 22R1 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.

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), including any system or metadata updates (such as a retrospective amendment being executed) 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

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

Coding Data

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

List of coding columns for MedDRA:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length
CRSTATUS Coding Status Text Char $ 200 $200
DICTTYPE Dictionary Type Text Char $ 200 $200
DICTVER Dictionary Release Text Char $ 200 $200
SOC SOC Text Char $ 200 $200
SOCID SOC Code Text Char $ 200 $200
HLGT HLGT Text Char $ 200 $200
HLGTID HLGT Code Text Char $ 200 $200
HLT HLT Text Char $ 200 $200
HLTID HLT Code Text Char $ 200 $200
PT PT Text Char $ 200 $200
PTID PT Code Text Char $ 200 $200
LLT LLT Text Char $ 200 $200
LLTID LLT Code Text Char $ 200 $200
PRIMPATH Primary Path Text Char $ 200 $200
LASTCODEDAT Last Coded Date Text Char $ 200 $200
LASTCODEBY Last Coded By Text Char $ 200 $200

List of coding columns for WHODrug:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length
CRSTATUS Coding Status Text Char $ 200 $200
DICTTYPE Dictionary Type Text Char $ 200 $200
DICTVER Dictionary Release Text Char $ 200 $200
ATC1 ATC1 Text Char $ 200 $200
ATC1CD ATC1 Code Text Char $ 200 $200
ATC2 ATC2 Text Char $ 200 $200
ATC2CD ATC2 Code Text Char $ 200 $200
ATC3 ATC3 Text Char $ 200 $200
ATC3CD ATC3 Code Text Char $ 200 $200
ATC4 ATC4 Text Char $ 200 $200
ATC4CD ATC4 Code Text Char $ 200 $200
PREFNAME Preferred Name Text Char $ 200 $200
PREFCODE Preferred Code Text Char $ 200 $200
DRUGNAME Drug Name Text Char $ 200 $200
DRUGCODE Drug Code Text Char $ 200 $200
PREFBASE Preferred Base Code Text Char $ 200 $200
PREFLABEL Preferred Base Text Char $ 200 $200
LASTCODEDAT Last Coded Date Text Char $ 200 $200
LASTCODEBY Last Coded By Text Char $ 200 $200

List of coding columns for JDrug:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length
CRSTATUS Coding Status Text Char $ 200 $200
DICTTYPE Dictionary Type Text Char $ 200 $200
DICTVER Dictionary Release Text Char $ 200 $200
DRUGCODE Drug Code Text Char $ 200 $200
DRUGNAME Drug Name Text Char $ 200 $200
GDRUGNAME Generic Drug Name Text Char $ 200 $200
DRUGCODECAT1 Drug Code Category 1 Text Char $ 200 $200
DRUGCODECAT2 Drug Code Category 2 Text Char $ 200 $200
USECAT1 Use Category 1 Text Char $ 200 $200
USECAT2 Use Category 2 Text Char $ 200 $200
MANNAME Manufacturer Name Text Char $ 200 $200
MANCODE Manufacturer Code Text Char $ 200 $200
MAINTFLG Maintenance Flag Text Char $ 200 $200
MAINTDT Maintenance Date Text Char $ 200 $200
LASTCODEDAT Last Coded Date Text Char $ 200 $200
LASTCODEDBY Last Coded By Text Char $ 200 $200

Definitions File

The Study Data Extract ZIP file contains a definition file, which is a listing of all columns across all datasets included in the extract.

List of columns included in the Definitions file:

Column Header Data
Dataset Name Name of the dataset
Column Name of the column
Type Item type for clinical data items
SAS Type SAS type of the column
SAS Informat SAS informat applied
SAS Format SAS format applied
Length Length in characters
SAS Length SAS length in bytes
Label SAS Label of the column

System Datasets

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
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
LASTMODDAT Last modified date/time of the event date (UTC) Datetime Num : vdatetime. DATETIME22.3 14 8
CASEBDEF Casebook Version Integer Num $ 20 $20
STATUS Status of the event/visit Text Char $ 100 $100
LASTREAS Last change reason Text Char $ 200 $200
WINSTAT Scheduled Window Status Text Char $ 100 $100
DAYSOW Days Outside Window Integer Num 14 8
EXPFORMS Expected Number of Forms Integer Num 14 8
FORMEOD Number of days past due when one or more forms is not yet complete Integer Num 14 8
GUID Internal Vault ID of the site Text Char $ 100 $100
LASTRUN Last run of this data/listing Datetime Num : vdatetime. DATETIME22.3 14 8

SYS_FORM

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

List of SYS_FORM columns:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length Notes
STUDYID Study Text Char $ 100 $100
COUNTRY Country Text Char $ 100 $100
SITENUM Study Site Number Text Char $ 100 $100
SUBJID Subject Text Char $ 100 $100
EGROUP Event Group Text Char $ 200 $200
EVENT Event Text Char $ 200 $200
EVENTEID Event External Id Text Char $ 200 $200
EVENTDT Event date Date Num : vdate. DATE9. 14 8
ESEQ Event Group Sequence Integer Num 14 8
FORM Form Text Char $ 200 $200
FORMEID Form External ID Text Char $ 100 $100
FSEQ Form Sequence Integer Num 14 8
STATUS Form Status Text Char $ 100 $100
CREATEDT Datetime form created Datetime Num : vdatetime. DATETIME22.3 14 8
SUBMITDT Datetime form last submitted Datetime Num : vdatetime. DATETIME22.3 14 8
NSUBMITS Number of times form was submitted Integer Num 14 8
SDVREQ SDV Required Boolean Char $ 1 $1 Not supported for SDV rollup V1 studies, will be blank
SDVDT Datetime considered SDV complete (UTC) Datetime Num : vdatetime. DATETIME22.3 14 8
SDVLAST Datetime of last SDV modification (UTC) Datetime Num : vdatetime. DATETIME22.3 14 8 Not supported for SDV rollup V1 studies, will be blank
TOSDV Days from submit to SDV Float Num 14 8
DMRREQ DMR Required Boolean Char $ 1 $1 Not supported for SDV rollup V1 studies, will be blank
DMRDT Datetime considered DMR complete Datetime Num : vdatetime. DATETIME22.3 14 8
DMRLAST Datetime of last DMR modification (UTC) Datetime Num : vdatetime. DATETIME22.3 14 8 Not supported for SDV rollup V1 studies, will be blank
TODMR Days from submit to DMR Float Num 14 8
FREEZEDT Datetime frozen (UTC) Datetime Num : vdatetime. DATETIME22.3 14 8
TOFREEZE Days from submit to freeze Float Num 14 8
LOCKDT Datetime locked (UTC) Datetime Num : vdatetime. DATETIME22.3 14 8
TOLOCK Days from submit to lock Float Num 14 8
SIGNDT Datetime signed (UTC) Datetime Num : vdatetime. DATETIME22.3 14 8
LSTSGNDT Last Signature Date Datetime Num : vdatetime. DATETIME22.3 14 8
TOSIGN Days from submit to sign Float Num 14 8
EDT_SUBM Days from event date (of form) to submit date Float Num 14 8
ILB Intentionally Left Blank Boolean Char $ 100 $100
ILBREAS Reason for Intentionally Left Blank Text Char $ 200 $200
GUID Internal Vault ID of the event Text Char $ 100 $100
LASTRUN Last run of this data/listing Datetime Num : vdatetime. DATETIME22.3 14 8

SYS_Q

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

List of SYS_Q columns:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length Notes
STUDYID Study Text Char $ 100 $100
COUNTRY Country Text Char $ 100 $100
SITENUM Study Site Number Text Char $ 100 $100
SUBJID Subject Text Char $ 100 $100
EGROUP Event Group Text Char $ 200 $200
EVENT Event Text Char $ 200 $200
EVENTEID Event External Id Text Char $ 200 $200
ESEQ Event Group Sequence Integer Num 14 8
FORM Form Text Char $ 200 $200
FORMEID Form External ID Text Char $ 100 $100
FSEQ Form Sequence Integer Num 14 8
ITEMGROUP Item group Text Char $ 200 $200
IGSEQ Item group sequence Integer Num 14 8
ITEM Item Text Char $ 500 $2000
QUERYID Query ID Text Char $ 200 $200
STATUS Query status Text Char $ 100 $100 Includes Open, Answered, 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.

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

List of SYS_QT columns:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length Notes
STUDYID Study Text Char $ 100 $100
COUNTRY Country Text Char $ 100 $100
SITENUM Study Site Number Text Char $ 100 $100
SUBJID Subject Text Char $ 100 $100
QUERYID Query ID Text Char $ 200 $200
STATUS Query status Text Char $ 100 $100 Includes Open, Answered, 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

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

List of SYS_LINKS columns:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length
STUDYID Study Text Char $ 100 $100
COUNTRY Country Text Char $ 100 $100
SITENUM Study Site Number Text Char $ 100 $100
SUBJID Subject Text Char $ 100 $100
EGROUP Event Group Text Char $ 200 $200
EVENT Event Text Char $ 200 $200
EVENTEID Event External Id Text Char $ 200 $200
ESEQ Event Group Sequence Integer Num 14 8
FORM Form Text Char $ 20 $20
FORMEID Form external ID Text Char $ 20 $20
FSEQ Form Sequence Integer Num 14 8
IGROUP Item Group Text Char $ 500 $2000
IGROUPDEF Item Group Definition Text Char $ 128 $512
IGSEQ Item Group Sequence Integer Num 14 8
ITEM Item Text Char $ 500 $2000
ITEMDEF Item Definition Text Char $ 128 $512
CREATED Created date/time (UTC) Datetime Num : vdatetime. DATETIME22.3 14 8
CREATEDB Created by Text Char $ 100 $100
FGUID Internal vault ID (forms) Text Char $ 100 $100
GUID Internal Vault ID of the site Text Char $ 100 $100
LASTRUN Last run of this data/listing Datetime of when the extract was run (UTC)

SYS_ASM

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

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

SYS_ASMR

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

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

SYS_PD

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

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length
STUDYID Study Text Char $ 100 $100
COUNTRY Country Text Char $ 100 $100
SITENUM Study Site Number Text Char $ 100 $100
SUBJID Subject Text Char $ 100 $100
PDID Protocol Deviation Identifier Text Char $ 200 $200
PDSUM Protocol Deviation Summary Text Char $ 1000 $1000
PDDAT Date of Deviation Date Num : vdate. DATE9. 14 8
PDDATID Date Identified Date Num : vdate. DATE9. 14 8
PDCAT Category Text Char $ 100 $100
PDCATLABEL Category Label Text Char $ 128 512
PDSUBCAT Subcategory Text Char $ 100 $100
PDSUBCATLABEL Subcategory Label Text Char $ 128 512
PDSEV Severity Text Char $ 100 $100
PDSEVLABEL Severity Label Text Char $ 128 512
PDDESC Description Text Char $ 1000 $1000
PDSTATUS Protocol Deviation Status Text Char $ 100 $100
PDRES Protocol Deviation Resolution Text Char $ 500 $2000
PDRULE Protocol Deviation Rule Text Char $ 100 $100
EGROUP Event Group Text Char $ 100 $100
EVENT Event Text Char $ 100 $100
ESEQ Event Group Sequence Integer Num 14 8
FORM Form Text Char $ 100 $100
FSEQ Form Sequence Integer Num 14 8
IGROUP Item Group Text Char $ 100 $100
IGSEQ Item Group Sequence Integer Num $ 100 $100
ITEM Item Text Char $ 500 $2000
CREATEDT Created Date/Time (UTC) Datetime Num : vdatetime. DATETIME22.3 14 8
CREATEDB Created By Text Char $ 100 $100
LASTMODDT Last Modified Date/Time (UTC) Datetime Num : vdatetime. DATETIME22.3 14 8
USERMODDT User Modified Date Text Char $ 100 $100
USERMODB User Modified By Text Char $ 100 $100
INACBYSYS Inactivated by System Boolean Char $ 100 $100
LASTINACDT Last Inactivated Date Datetime Num : vdatetime. DATETIME22.3 14 8
FGUID Internal Vault ID of Form Text Char $ 100 400
PDGUID Internal Vault ID of Protocol Deviation Text Char $ 15 60
LASTRUN Last run of this data/listing Datetime Num : vdatetime. DATETIME22.3 14 8

SYS_RAND

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

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length Notes
STUDYID Study Text Char $ 100 $100
COUNTRY Country Text Char $ 100 $100
SITE Study Site Number Text Char $ 100 $100
SUBJID Subject Text Char $ 100 $100
RANDSTATUS Randomization Status Text Char $ 200 $200
RANDID Randomization ID Text Char $ 200 $200
TREATMENTNAME* Treatment Name Text Char $ 200 $200
TREATMENTLABEL* Treatment Label Text Char $ 1500 $1500
TREATMENTARM* Treatment Arm Text Char $ 200 $200 Visible if "Include Randomization Treatment" is selected in SDE Version 22R1 or later
RANDSTRATA Strata Group Text Char $ 200 $200
RANDBY Randomized By Text Char $ 200 $200
RANDDAT Randomized Date Datetime Num : vdatetime. DATETIME22.3 14 8
RANDFILE Randomization File Label Text Char $ 200 $200
RANDFILEDAT Randomization File Upload Date Datetime Num : vdatetime. DATETIME22.3 14 8
LASTRUN Last run of this data/listing Datetime Num : vdatetime. DATETIME22.3 14 8

*These columns are only available for unmasked studies with Randomization enabled. 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 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

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 SAS Format Length SAS Length
CRSTATUS Coding Status Text Char $ 200 $200
DICTTYPE Dictionary Type Text Char $ 200 $200
DICTVER Dictionary Release Text Char $ 200 $200
SOC SOC Text Char $ 200 $200
SOCID SOC Code Text Char $ 200 $200
HLGT HLGT Text Char $ 200 $200
HLGTID HLGT Code Text Char $ 200 $200
HLT HLT Text Char $ 200 $200
HLTID HLT Code Text Char $ 200 $200
PT PT Text Char $ 200 $200
PTID PT Code Text Char $ 200 $200
LLT LLT Text Char $ 200 $200
LLTID LLT Code Text Char $ 200 $200
PRIMPATH Primary Path Text Char $ 200 $200
LASTCODEDAT Last Coded Date Text Char $ 200 $200
LASTCODEBY Last Coded By Text Char $ 200 $200

List of coding columns for WHODrug:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length
CRSTATUS Coding Status Text Char $ 200 $200
DICTTYPE Dictionary Type Text Char $ 200 $200
DICTVER Dictionary Release Text Char $ 200 $200
ATC1 ATC1 Text Char $ 200 $200
ATC1CD ATC1 Code Text Char $ 200 $200
ATC2 ATC2 Text Char $ 200 $200
ATC2CD ATC2 Code Text Char $ 200 $200
ATC3 ATC3 Text Char $ 200 $200
ATC3CD ATC3 Code Text Char $ 200 $200
ATC4 ATC4 Text Char $ 200 $200
ATC4CD ATC4 Code Text Char $ 200 $200
PREFNAME Preferred Name Text Char $ 200 $200
PREFCODE Preferred Code Text Char $ 200 $200
DRUGNAME Drug Name Text Char $ 200 $200
DRUGCODE Drug Code Text Char $ 200 $200
PREFBASE Preferred Base Code Text Char $ 200 $200
PREFLABEL Preferred Base Text Char $ 200 $200
LASTCODEDAT Last Coded Date Text Char $ 200 $200
LASTCODEBY Last Coded By Text Char $ 200 $200

List of coding columns for JDrug:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length
CRSTATUS Coding Status Text Char $ 200 $200
DICTTYPE Dictionary Type Text Char $ 200 $200
DICTVER Dictionary Release Text Char $ 200 $200
DRUGCODE Drug Code Text Char $ 200 $200
DRUGNAME Drug Name Text Char $ 200 $200
GDRUGNAME Generic Drug Name Text Char $ 200 $200
DRUGCODECAT1 Drug Code Category 1 Text Char $ 200 $200
DRUGCODECAT2 Drug Code Category 2 Text Char $ 200 $200
USECAT1 Use Category 1 Text Char $ 200 $200
USECAT2 Use Category 2 Text Char $ 200 $200
MANNAME Manufacturer Name Text Char $ 200 $200
MANCODE Manufacturer Code Text Char $ 200 $200
MAINTFLG Maintenance Flag Text Char $ 200 $200
MAINTDT Maintenance Date Text Char $ 200 $200
LASTCODEDAT Last Coded Date Text Char $ 200 $200
LASTCODEDBY Last Coded By Text Char $ 200 $200

Definitions File

The Study Data Extract ZIP file contains a definition file, which is a listing of all columns across all datasets included in the extract.

List of columns included in the Definitions file:

Column Header Data
Dataset Name Name of the dataset
Column Name of the column
Type Item type for clinical data items
SAS Type SAS type of the column
SAS Informat SAS informat applied
SAS Format SAS format applied
Length Length in characters
SAS Length SAS length in bytes
Label SAS Label of the column

System Datasets

SYS_SITE

The SYS_SITE dataset lists all sites for the selected study.

List of SYS_SITE columns:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length
STUDYID Study Text Char $ 100 100
COUNTRY Study Country Text Char $ 100 100
SITENUM Study Site Number Text Char $ 100 100
SITENAME Study Site Name Text Char $ 100 100
INVNAME Principal Investigator Text Char $ 100 100
CASEBDEF Casebook Version Integer Char $ 100 100
STATUS Site Status Text Char $ 100 100
TIMEZONE Timezone of the Site Text Char $ 100 100
GUID Internal Vault ID of the site Text Char $ 100 100
LASTRUN Last run of this data/listing Datetime Num : vdatetime. DATETIME22.3 14 8

SYS_SUB

The SYS_SUB dataset lists all subjects for the selected study.

List of SYS_SUB columns:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length
STUDYID Study Text Char $ 100 100
COUNTRY Country Text Char $ 100 100
SITENUM Study Site Number Text Char $ 100 100
SUBJID Subject Text Char $ 100 100
CASEBDEF Casebook Version Integer Char $ 100 100
STATUS Status of the Subject/Casebook Text Char $ 100 100
GUID Internal Vault ID of the site Text Char $ 100 100
LASTRUN Last run of this data/listing Datetime Num : vdatetime. DATETIME22.3 14 8
CNSNTDT Initial Consent Date Date Num : vdate. DATE9. 14 8
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

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

List of SYS_LINKS columns:

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

SYS_ASM

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

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

SYS_ASMR

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

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

SYS_PD

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

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

SYS_RAND

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

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

SYS_LABRANGES

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

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

SYS_LABLOC

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

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

SYS_ANALYTES

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

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

21R2 Version

Clinical Datasets

Each clinical dataset, and each Form (Adverse Events, Concomitant Medications, etc.), contains a set of Key Columns and a set of Clinical Data columns, which are detailed below.

Key Columns

Key Columns contain data to help identify which Form each row is referring to (ex: which Subject, Site, Cycle, or Event that particular form is located in).

The list of Key Columns is as follows:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length
STUDYID Study Text Char $ 100 $100
COUNTRY Country Text Char $ 100 $100
SITE Site Text Char $ 100 $100
SUBJID Subject Text Char $ 100 $100
EGROUP Event Group Text Char $ 200 $200
EVENT Event Text Char $ 200 $200
EVENTID Event External ID Text Char $ 100 $100
EVENTDT Event Date Date Num : vdate. DATE9. 14 8
ESEQ Event Sequence Integer Num 14 8
FORM Form Text Char $ 200 $200
FORMEID Form External ID Text Char $ 100 $100
FSEQ Form Sequence Integer Num 14 8
IGSEQ Item Group Sequence Integer Num 14 8
DLASTMOD* Datetime of Last Data Change (UTC) Datetime Num : vdatetime. DATETIME22.3 14 8
FGUID Internal Vault ID (Forms) Text Char $ 200 $200
IGGUID Internal Vault ID (item groups) Text Char $ 1000 $1000
FORMILB Intentionally Left Blank Boolean Char $ 1 $1
LASTRUN Last run of this data/listing Datetime Num : vdatetime. DATETIME22.3 14 8
LINKEDTO Links to other forms Text Char $ 1500 $1500

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

Coding Data

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

List of coding columns for MedDRA:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length
CRSTATUS Coding Status Text Char $ 200 $200
DICTTYPE Dictionary Type Text Char $ 200 $200
DICTVER Dictionary Release Text Char $ 200 $200
SOC SOC Text Char $ 200 $200
SOCID SOC ID Text Char $ 200 $200
HLGT HLGT Text Char $ 200 $200
HLGT ID HLGT ID Text Char $ 200 $200
HLT HLT Text Char $ 200 $200
HLT ID HLT ID Text Char $ 200 $200
PT PT Text Char $ 200 $200
PT ID PT ID Text Char $ 200 $200
LLT LLT Text Char $ 200 $200
LLT ID LLT ID Text Char $ 200 $200
PRIMPATH Primary Path Text Char $ 200 $200
LASTCODEDAT Last Coded Date Text Char $ 200 $200
LASTCODEBY Last Coded By Text Char $ 200 $200

List of coding columns for WHODrug:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length
CRSTATUS Coding Status Text Char $ 200 $200
DICTTYPE Dictionary Type Text Char $ 200 $200
DICTVER Dictionary Release Text Char $ 200 $200
ATC1 ATC1 Text Char $ 200 $200
ATC1CD ATC1 Code Text Char $ 200 $200
ATC2 ATC2 Text Char $ 200 $200
ATC2CD ATC2 Code Text Char $ 200 $200
ATC3 ATC3 Text Char $ 200 $200
ATC3CD ATC3 Code Text Char $ 200 $200
ATC4 ATC4 Text Char $ 200 $200
ATC4CD ATC4 Code Text Char $ 200 $200
PREFNAME Preferred Name Text Char $ 200 $200
PREFCODE Preferred Code Text Char $ 200 $200
DRUGNAME Drug Name Text Char $ 200 $200
DRUGCODE Drug Code Text Char $ 200 $200
PREFBASE Preferred Base Code Text Char $ 200 $200
PREFLABEL Preferred Base Text Char $ 200 $200
LASTCODEDAT Last Coded Date Text Char $ 200 $200
LASTCODEBY Last Coded By Text Char $ 200 $200

List of coding columns for JDrug:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length
CRSTATUS Coding Status Text Char $ 200 $200
DICTTYPE Dictionary Type Text Char $ 200 $200
DICTVER Dictionary Release Text Char $ 200 $200
DRUGCODE Drug Code Text Char $ 200 $200
DRUGNAME Drug Name Text Char $ 200 $200
GDRUGNAME Generic Drug Name Text Char $ 200 $200
DRUGCODECAT1 Drug Code Category 1 Text Char $ 200 $200
DRUGCODECAT2 Drug Code Category 2 Text Char $ 200 $200
USECAT1 Use Category 1 Text Char $ 200 $200
USECAT2 Use Category 2 Text Char $ 200 $200
MANNAME Manufacturer Name Text Char $ 200 $200
MANCODE Manufacturer Code Text Char $ 200 $200
MAINTFLG Maintenance Flag Text Char $ 200 $200
MAINTDT Maintenance Date Text Char $ 200 $200
LASTCODEDAT Last Coded Date Text Char $ 200 $200
LASTCODEDBY Last Coded By Text Char $ 200 $200

Definitions File

The Study Data Extract ZIP file contains a definition file, which is a listing of all columns across all datasets included in the extract.

List of columns included in the Definitions file:

Column Header Data
Dataset Name Name of the dataset
Column Name of the column
Type Item type for clinical data items
SAS Type SAS type of the column
SAS Informat SAS informat applied
SAS Format SAS format applied
Length Length in characters
SAS Length SAS length in bytes
Label SAS Label of the column

System Datasets

SYS_SITE

The SYS_SITE dataset lists all sites for the selected study.

List of SYS_SITE columns:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length
STUDYID Study Text Char $ 100 100
COUNTRY Study Country Text Char $ 100 100
SITENUM Study Site Number Text Char $ 100 100
SITENAME Study Site Name Text Char $ 100 100
INVNAME Principal Investigator Text Char $ 100 100
CASEBDEF Casebook Version Integer Char $ 100 100
STATUS Site Status Text Char $ 100 100
TIMEZONE Timezone of the Site Text Char $ 100 100
GUID Internal Vault ID of the site Text Char $ 100 100
LASTRUN Last run of this data/listing Datetime Num : vdatetime. DATETIME22.3 14 8

SYS_SUB

The SYS_SUB dataset lists all subjects for the selected study.

List of SYS_SUB columns:

Column Header Label Type SAS Type SAS Informat SAS Format Length SAS Length
STUDYID Study Text Char $ 100 100
COUNTRY Country Text Char $ 100 100
SITENUM Study Site Number Text Char $ 100 100
SUBJID Subject Text Char $ 100 100
CASEBDEF Casebook Version Integer Char $ 100 100
STATUS Status of the Subject/Casebook Text Char $ 100 100
GUID Internal Vault ID of the site Text Char $ 100 100
LASTRUN Last run of this data/listing Datetime Num : vdatetime. DATETIME22.3 14 8
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
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

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
EVENT Event Text Char $ 200 $200
EVENTDT Event Date Date Num : vdate. DATE9 14 8
ESEQ Event Group Sequence Integer Num 14 8
CASEBDEF Casebook Version Integer Char $ 20 $20
STATUS Status of the event/visit Text Char $ 100 $100
LASTREAS Last change reason Text Char $ 200 $200
GUID Internal Vault ID of the site Text Char $ 100 $100
LASTRUN Last run of this data/listing Datetime Num : vdatetime. DATETIME22.3 14 8

SYS_FORM

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

List of SYS_FORM columns:

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

SYS_Q

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

List of SYS_Q columns:

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

SYS_QT

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

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

List of SYS_QT columns:

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

SYS_ILB

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

List of SYS_ILB columns:

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

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 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 $ 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 $ 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

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