| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format1 | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
| RDOMAIN | Related Domain Abbreviation | Char | (DOMAIN) | Identifier | Abbreviation for the domain of the parent record(s). | Req |
| USUBJID | Unique Subject Identifier | Char |
| Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Exp |
| IDVAR | Identifying Variable | Char |
| Identifier | Name of the identifying variable in the general-observation-class dataset that identifies the related record(s). Examples include --SEQ and --GRPID. | Req |
| IDVARVAL | Identifying Variable Value | Char |
| Identifier | Value of identifying variable described in IDVAR. If --SEQ is the variable being used to describe this record, then the value of --SEQ would be entered here. | Exp |
| RELTYPE | Relationship Type | Char | (RELTYPE) | Record Qualifier | Identifies the hierarchical level of the records in the relationship. Values should be either ONE or MANY. Used only when identifying a relationship between datasets). | Exp |
| RELID | Relationship Identifier | Char |
| Record Qualifier | Unique value within USUBJID that identifies the relationship. All records for the same USUBJID that have the same RELID are considered "related/associated." RELID can be any value the applicant chooses, and is only meaningful within the RELREC dataset to identify the related/associated Domain records. | Req |