1 | RELREC | STUDYID | Study Identifier | Char | | Identifier | Req | Unique identifier for a study. |
2 | RELREC | RDOMAIN | Related Domain Abbreviation | Char | C66734 | Identifier | Req | Abbreviation for the domain of the parent record(s). |
3 | RELREC | USUBJID | Unique Subject Identifier | Char | | Identifier | 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 | | Identifier | Req | Name of the identifying variable in the general-observation-class dataset that identifies the related record(s). Examples: --SEQ, --GRPID. |
5 | RELREC | IDVARVAL | Identifying Variable Value | Char | | Identifier | 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 | C78737 | Record Qualifier | 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, Relating Datasets). |
7 | RELREC | RELID | Relationship Identifier | Char | | Record Qualifier | 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. |