1 | RELREC | STUDYID | Study Identifier | Char | | | Req | Unique identifier for a study |
2 | RELREC | RDOMAIN | Related Domain Abbreviation | Char | C66734 | | Req | Two-character abbreviation for the domain of the parent record(s) |
3 | RELREC | USUBJID | Unique Subject Identifier | Char | | | Exp | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. |
4 | RELREC | IDVAR | Identifying Variable | Char | | | Req | Name of the identifying variable in the general-observation-class dataset that identifies the related record(s). Examples include --SEQ and --GRPID. |
5 | RELREC | IDVARVAL | Identifying Variable Value | Char | | | Exp | 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. |
6 | RELREC | RELTYPE | Relationship Type | Char | | | Exp | 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 (as described in Section 8.3). |
7 | RELREC | RELID | Relationship Identifier | Char | | | Req | 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 sponsor chooses, and is only meaningful within the RELREC dataset to identify the related/associated Domain records. |