| # | 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. | Study identifier of the domain record(s). |
|
| 2 | DOMAIN | Domain Abbreviation | Char |
| Identifier |
|
| C49558 | An abbreviation for a collection of observations, with a topic-specific commonality. | 2-character abbreviation, which must be "DR". |
|
| 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 | SPDEVID | Sponsor Device Identifier | Char |
| Identifier |
|
|
|
| Sponsor-defined identifier for the device. It must be unique for each tracked unit of the device under study, and can be at whatever level of granularity the device should be identified (e.g., model or serial number, combination of identifiers) as defined in DI. |
|