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Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

STUDYID

Study Identifier

Char

Req

DM.STUDYID

USUBJID

Unique Subject Identifier

Char

Req

DM.USUBJID

SUBJID

Subject Identifier for the Study

Char

Req

DM.SUBJID. SUBJID is required in ADSL, but permissible in other datasets.

SITEID

Study Site Identifier

Char

Req

DM.SITEID. SITEID is required in ADSL, but permissible in other datasets.

SITEGRy

Pooled Site Group y

Char

Perm

Character 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.

SITEGRyN

Pooled 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.

REGIONy

Geographic Region y

Char

Perm

Character 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".

REGIONyN

Geographic 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.