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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).


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.