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:
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The Automap feature for transformations uses all SDTM identifiers.
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Filtering in the Listings pages requires the USUBJID and VISITNUM SDTM identifiers.
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Filtering in the Discrepancies pages requires the SUBJID and VISIT SDTM identifiers.
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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.
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Subject Visit unit of work processing requires the USUBJID and VISITNUM SDTM identifiers.
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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 |
Parent topic: Advanced topics