Variable Name | Variable Label | Type | Codelist | Controlled Terms | Core | SubClass ADVERSE EVENT Core | CDISC Notes |
STUDYID | Study Identifier | Char | Req | Req | XX.STUDYID | ||
USUBJID | Unique Subject Identifier | Char | Req | Req | XX.USUBJID | ||
SUBJID | Subject Identifier for the Study | Char | Perm | Perm | ADSL.SUBJID | ||
SITEID | Study Site Identifier | Char | Perm | Perm | ADSL.SITEID |
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.
Note: SRCDOM and SRCSEQ are described in ADaMIG Section 3.3.9, Datapoint Traceability Variables, as part of BDS datapoint traceability. The BDS data-point traceability variable SRCVAR is not included in OCCDS; SRCVAR is used to hold the name of the primary variable used to derive AVAL or AVALC in BDS, but AVAL and AVALC are not applicable to OCCDS. (For additional guidance, see the ADaMIG; https://www.cdisc.org/standards/foundational/adam).
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