Use SDTM identifiers to support important functionality

In all clinical data model tables, it's important to link columns to SDTM identifiers in the Filter/SDTM field to support key DMW functionality:

  • The Automap feature for transformations uses all SDTM identifiers.

  • Filtering in the Listings pages requires the USUBJID and VISITNUM SDTM identifiers.

  • Filtering in the Discrepancies pages requires the SUBJID and VISIT SDTM identifiers.

  • To display the subject ID and visit name in TMS for TMS discrepancies, assign those SDTM IDs to the appropriate columns in any table you map to a TMS Set.

  • Subject Visit unit of work processing requires the USUBJID and VISITNUM SDTM identifiers.

  • Subject unit of work processing requires the SUBJID SDTM identifier.

Table 8-3 SDTM Column Identifiers Available for Use in DMW

SDTM ID Meaning Data Type In Default Subject Visit Table? In Default Subject Table?

~

Actual Visit Date (Not an SDTM variable but used as one by the DMW Automap feature.)

date

No

No

COUNTRY

Country of Investigator Site

varchar2

No

Yes

INVNAM

Investigator Name

varchar2

No

No

INVID

Investigator ID

varchar2

No

No

SITEID

Site ID

varchar2

No

Yes

~

Site Name (Not an SDTM variable but used as one by the DMW Automap feature.)

varchar2

No

No

STUDYID

Study Identifier is the unique ID of the study.

varchar2

Yes

Yes

SUBJID

Subject ID unique within study

varchar2

No

No

USUBJID

Unique Subject ID unique across all studies for all applications or submissions involving the product.

varchar2

Yes

Yes

EPOCH

Visit Cycle is an interval of time in the planned conduct of a study, associated with a purpose such as screening, randomization, treatment, or follow-up, that applies across all arms of a study.

varchar2

No

Yes

VISIT

Visit Name is the protocol-defined description of the clinical encounter or description of unplanned visit.

varchar2

Yes

No

VISITDY

Visit Day Planned study day of visit.

varchar2

Yes

No

VISITNUM

Visit Number is a numeric version of VISIT, used for sorting. Decimal numbering may be useful for inserting unplanned visits.

number

Yes

No

SVSTDTC

Visit Start Date (Start Date/Time of Visit) is the start date/time of a subject's visit, represented in ISO 8601 character format.

varchar2

Yes

No