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Table 3.3.1.1 Identifier Variables for BDS Datasets

Metadataspec
keysCore;CDISC Notes

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

STUDYID

Study Identifier

Char


Req

DM.STUDYID, ADSL STUDYID, and/or STUDYID from another ADaM or SDTM dataset appropriate to the analysis.

USUBJID

Unique Subject Identifier

Char


Req

DM.USUBJID, ADSL.USUBJID, and/or USUBJID from another ADaM or SDTM dataset appropriate to the analysis.

SUBJID

Subject Identifier for the Study

Char


Perm

DM.SUBJID, ADSL.SUBJID, and/or SUBJID from another ADaM dataset appropriate to the analysis. SUBJID is required in ADSL, but permissible in other datasets.

SITEID

Study Site Identifier

Char


Perm

DM.SITEID, ADSL.SITEID, and/or SITEID from another ADaM dataset appropriate to the analysis. SITEID is required in ADSL, but permissible in other datasets.

ASEQ

Analysis Sequence Number

Num


Perm

Sequence number given to ensure uniqueness of subject records within an ADaM dataset. As long as values are unique within a subject within the dataset, any valid number can be used for ASEQ. ASEQ uniquely indexes records within a subject within an ADaM dataset.

ASEQ is useful for traceability when the dataset is used as input to another ADaM dataset. To refer to a record in a predecessor ADaM dataset, set SRCDOM to the name of the predecessor dataset, and set SRCSEQ to the value of ASEQ in the predecessor dataset.