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Any SDTM timing variable (including, but not limited to EPOCH, --DTC, --DY, VISITNUM, VISIT, and VISITDY) may be copied into ADaM datasets when it supports data traceability and/or shows how ADaM timing variables contrast with SDTM timing data. If a dataset contains more than 1 record within a parameter and within a subject, then an SDTM or ADaM relative timing variable must be present (eg, ADY, ASTDY, AENDY, AVISIT, ATPT).

ADaMIG Table 3.3.3.1 defines analysis timing variables for BDS datasets. The timing variables whose names start with the letter A are the timing variables directly associated with the AVAL and AVALC variables in the ADaM dataset.

A variable for relative day of measurement or event, along with timing variables for visit, should be included when an ADaM dataset contains multiple records per subject (i.e., repeated measures data). 

Timing variables not directly characterizing AVAL (e.g., *DT) should be prefixed by a character string instead of the placeholder asterisk shown in ADaMIG Table 3.3.3.3, so that their actual names comply with the variable naming conventions described in Section 2.9.3.1, General Variable Conventions. In many cases, the prefix for these date and time variables would match that of an SDTM --DTC, --STDTC or --ENDTC variable name. For example, if a numeric date variable were created from --STDTC, then it would be named --SDT. However, if --DTC or --STDTC is the date that is associated with AVAL and AVALC, its numeric equivalent should be named ADT or ASTDT, as appropriate. The timing variable conventions documented in Section 2.9.3.2, Timing Variable Conventions, apply here as well.

Period, Subperiod, and Phase Start and End Timing Variables

Suffixes for Producer-defined Timing Variables in BDS Datasets