| STUDYID |
Study Identifier |
Char |
Identifier |
Unique identifier for a study. |
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.
Either USUBJID or POOLID must be populated. |
Exp |
| POOLID |
Pool Identifier |
Char |
Identifier |
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. |
Perm |
| RSUBJID |
Related Subject or Pool Identifier |
Char |
Identifier |
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. |
Req |
| SREL |
Subject Relationship |
Char |
Record Qualifier |
Describes the relationship of the subject identified in
USUBJID or the pool identified in POOLID to the subject or pool
identified in RSUBJID. |
Req |