| # | 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 | POOLID | Pool Identifier | Char |
| Identifier |
|
| C117053 | A sequence of characters used to uniquely identify a group of subjects that have been pooled together. | Used to identify a result that is not assignable to a specific subject. |
|
| 3 | 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. |
|
|
| 4 | APID | Associated Persons Identifier | Char |
| Identifier |
|
|
|
| Identifier for a single associated person, a group of associated persons, or a pool of associated persons. |
|