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OCCDS Identifier Variables

In addition to the above identifiers, row identifiers are included to support datapoint traceability. The combination of dataset or domain name and the relevant sequence number, when used in conjunction with USUBJID, provide datapoint traceability. There are 2 row identifier options: --SEQ or the combination of SRCDOM + SRCSEQ.

Commonly, rows in an OCCDS dataset are created from a single SDTM domain. In this case, --SEQ provides all of the row identifier (and thus datapoint traceability) information: The 2-letter prefix of the variable name is the SDTM domain name, and the content is the relevant sequence number.

Less commonly, rows in an OCCDS dataset are from multiple SDTM domains or from 1 or more ADaM datasets. Either the --SEQ variable from each domain can be added, or the variables SRCDOM and SRCSEQ can be used to identify the input rows.

For the ADVERSE EVENT SubClass, when data from FA is used in the ADVERSE EVENT SubClass, a unique identifier variable, such as FASEQ or FASPID, is also required for traceability

Row Identifier Variables