This dataset identifies individual subjects included in a pool of subjects for which a single observation record (pool level) is captured.
POOLDEF Dataset
SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes
| # | 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. |
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