The Device-subject Relationships (DR) domain is a special-purpose domain that links each subject to the associated devices. Information in this domain may have been collected and submitted in other domains (e.g., Device Exposure, Device Tracking and Disposition, Device Events). This domain, however, provides a single, consistent location to find the relationship between a subject and a device, regardless of the device or the domain in which subject-related data may have been collected or submitted.
Device-subject Relationships 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. | 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. |
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