Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format1 | Role | CDISC Notes | Core |
|---|
STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
DOMAIN | Domain Abbreviation | Char | DI | Identifier | Two-character abbreviation for the domain. | Req |
SPDEVID | Applicant Device Identifier | Char |
| Identifier | Applicant-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). | Req |
DISEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness within a parameter within a device (SPDEVID) within dataset. If there is only one value for DIPARMCD for each value of SPDEVID, then DISEQ will be 1 for all records. DISEQ must be a valid number. | Exp |
DIPARMCD | Device Identifier Element Short Name | Char* |
| Topic | Short name of the identifier characteristic of the device (e.g., "SERIAL", "MODEL"). A record with DIPARMCD = "DEVTYPE" should be included (see below). | Req |
DIPARM | Device Identifier Element Name | Char* |
| Synonym Qualifier | Name of the identifier characteristic of the device. Examples: Serial Number, Model. A record with DIPARM = "DEVTYPE" should be included (see below). | Req |
DIVAL | Device Identifier Element Value | Char* |
| Result Qualifier | Value for the parameter. Value for the parameter. When DIPARMCD=DEVTYPE it should use controlled terminology defined by FDA in their Preferred Term codelist. FDA has stated a preference for the Global Medical Device Nomenclature (GMDN), but as of the date of this publication, the GMDN is not freely available to the public. In its Unique Device Identification rule, FDA indicated that GMDN will not be required unless it is available to the public at no cost. There is a lookup tool on the FDA website to map GMDN codes to FDA PT codes. | Req |