1 | RELSUB | STUDYID | Study Identifier | Char | | Identifier | Req | Unique identifier for a study. |
2 | RELSUB | 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. Either USUBJID or POOLID must be populated. |
3 | RELSUB | POOLID | Pool Identifier | Char | | Identifier | Perm | Identifier used to identify a pool of subjects. If POOLID is entered, POOLDEF records must exist for each subject in the pool and USUBJID must be null. Either USUBJID or POOLID must be populated. |
4 | RELSUB | RSUBJID | Related Subject or Pool Identifier | Char | | Identifier | Req | Identifier used to identify a related subject or pool of subjects. RSUBJID will be populated with either the USUBJID of the related subject or the POOLID of the related pool. |
5 | RELSUB | SREL | Subject Relationship | Char | C100130 | Record Qualifier | Req | Describes the relationship of the subject identified in USUBJID or the pool identified in POOLID to the subject or pool identified in RSUBJID. |