| # | Variable Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples |
|---|
| 1 | STUDYID | Study Identifier | Char |
| Identifier |
|
| C83082 | A sequence of characters used by the sponsor to uniquely identify the study. |
|
|
| 2 | USUBJID | Unique Subject Identifier | Char |
| Identifier |
|
| C69256 | A sequence of characters 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 | POOLID | Pool Identifier | Char |
| Identifier |
|
| C117053 | A sequence of characters used to uniquely identify a group of subjects that have been pooled together. | 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 | 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. |
|
| 5 | 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. |
|