| 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. |