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Table 3.2.1 ADSL Identifier Variables

Variable NameVariable LabelTypeCodelist/ Controlled TermsCoreCDISC Notes
STUDYIDStudy IdentifierChar
ReqDM.STUDYID
USUBJIDUnique Subject IdentifierChar
ReqDM.USUBJID
SUBJIDSubject Identifier for the StudyChar
ReqDM.SUBJID. SUBJID is required in ADSL, but permissible in other datasets.
SITEIDStudy Site IdentifierChar
ReqDM.SITEID. SITEID is required in ADSL, but permissible in other datasets.
SITEGRyPooled Site Group yChar
PermCharacter description of a grouping or pooling of clinical sites for analysis purposes. For example, SITEGR3 is the name of a variable containing site group (pooled site) names, where the grouping has been done according to the third site grouping algorithm, defined in variable metadata; SITEGR3 does not mean the third group of sites.
SITEGRyNPooled Site Group y (N)Num
Perm

Numeric representation of SITEGRy. There must be a one-to-one relationship between SITEGRyN and SITEGRy within a study.

SITEGRyN cannot be present unless SITEGRy is also present. When SITEGRy and SITEGRyN are present, then on a given record, either both must be populated or both must be null.

REGIONyGeographic Region yChar
PermCharacter description of geographical region. For example, REGION1 might have values of "Asia", "Europe", "North America", "Rest of World"; REGION2 might have values of "United States", "Rest of World".
REGIONyNGeographic Region y (N)Num
Perm

Numeric representation of REGIONy. Orders REGIONy for analysis and reporting.There must be a one-to-one relationship between REGIONyN and REGIONy within a study.

REGIONyN cannot be present unless REGIONy is also present. When REGIONy and REGIONyN are present, then on a given record, either both must be populated or both must be null.

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