OCCDS Identifier Variables
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.
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
Variable Name | Variable Label | Type | Codelist | Controlled Terms | Core | SubClass ADVERSE EVENT Core | CDISC Notes |
--SEQ | Sequence Number | Num | Cond | Req | XX.--SEQ Identifies the sequence number in SDTM domain XX that is the source for this row. This variable would be copied unchanged from the SDTM domain XX. Required for traceability back to SDTM when rows in the dataset are created from a single SDTM domain. This may be missing for derived rows. For SubClass ADVERSE EVENT, use AESEQ, copied from SDTM AE.AESEQ. | ||
SRCDOM | Source Data | Char | Perm | Not used | Identifies the name of the domain or dataset that is the source for this row. If the source data is a supplemental qualifier in SDTM, this variable will contain the value of RDOMAIN in SUPP-- or SUPPQUAL. Used when rows in the OCCDS dataset are from multiple SDTM domains or from one or more ADaM datasets. Not to be used in conjunction with --SEQ. This may be missing for derived rows. For SubClass ADVERSE EVENT, AESEQ is used rather than SRCDOM and SRCSEQ. | ||
SRCSEQ | Source Sequence Number | Num | Perm | Not used | Identifies the sequence number that is the source for this row. If SRCDOM is a SUPPQUAL, then this variable will contain the sequence number of the relevant related domain record. Used when rows in the OCCDS dataset are from multiple SDTM domains or from one or more ADaM datasets. Not to be used in conjunction with --SEQ. This may be missing for derived rows. For SubClass ADVERSE EVENT, AESEQ is used rather than SRCDOM and SRCSEQ. | ||
ASEQ | Analysis Sequence Number | Num | Perm | Perm | Sequence number given to ensure uniqueness of subject records within an ADaM dataset. ASEQ is useful for traceability when the OCCDS dataset is used as input to another ADaM dataset and the --SEQ variable is not included or unique. ASEQ is described in more detail in ADaMIG v1.2, Section 3.3.1, Identifier Variables for BDS Datasets. |
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