The identity of a device is established by means of a number of parameters, then assigned an identifier. The parameters used for identification of a device depend on the kind of device and the need of the study to distinguish among devices.
Device Identifiers Dataset
SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
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| # | 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 | DOMAIN | Domain Abbreviation | Char | Identifier | C49558 | An abbreviation for a collection of observations, with a topic-specific commonality. | 2-character abbreviation, which must be "DI". | ||||
| 3 | SPDEVID | Sponsor Device Identifier | Char | Identifier | Sponsor-defined identifier for the device. | ||||||
| 4 | DISEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness within a parameter within a device (SPDEVID). | ||||||
| 5 | DIPARMCD | Device Identifier Element Short Name | Char | Topic | Short name of the identifier characteristic of the device. | ||||||
| 6 | DIPARM | Device Identifier Element Name | Char | Synonym Qualifier | DIPARMCD | Name of the identifier characteristic of the device. | |||||
| 7 | DIVAL | Device Identifier Element Value | Char | Result Qualifier | Value for the parameter. |
Concept Map. Relationships Between Device Identifier Variables
Overview
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