| 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 | DO | Identifier | Two-character abbreviation for the domain. | Req |
| SPDEVID | Sponsor Applicant Device Identifier | Char |
| Identifier | SponsorApplicant-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 |
| DOSEQ | Sequence Number | Num |
| Identifier | Sequence Number given to ensure uniqueness of device records within subject records within a domain. May be any valid number. It should be unique within every subject/device combination. | Req |
| DOGRPID | Group ID | Char |
| Identifier | Used to tie together a block of related records in a single domain for a device. | Perm |
| DOREFID | Reference ID | Char |
| Identifier | Internal or external identifier. This could be a scan code or equivalent. | Perm |
| SponsorApplicant-Defined Identifier | Char |
| Identifier | SponsorApplicant-defined reference number. | Perm |
| DOTESTCD | Device Property Short Name | Char | (DOTESTCD) | Topic | Short name of the measurement, test, or examination described in DOTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in DOTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST"). DOTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "SHLFLIFE", "INDC", "COMPOS". | Req |
| DOTEST | Device Property Test Name | Char | (DOTEST) | Synonym Qualifier | Verbatim name of the test or examination used to obtain the measurement or finding. The value in DOTEST cannot be longer than 40 characters. Examples: "Shelf Life", "Indication for use", "Composition" (of device). | Req |
| DOCAT | Category for Device In-Use | Char | * |
| Grouping Qualifier | Defines a category of related records. For example, it can be used to define the type of property being defined, such as "DIMENSIONS" versus "MATERIAL". | Perm |
| DOSCAT | Subcategory for Device In-Use | Char* |
| Grouping Qualifier | A further categorization of a measurement or examination. For example, if DOCAT = "DIMENSION", DOSCAT might be "LENGTH" or "WIDTH" or "THICKNESS". | Perm |
| DOORRES | Result or Finding in Original Units | Char |
| Result Qualifier | Result of the Device Property as originally observed or collected. DOORRES should contain the result or value of the property defined in DOTEST. For example, if DOTEST is LIFE (shelf life), then DOORRES might be 6 (months). | Exp |
| DOORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original units in which the data were collected. The unit for DOORRES. Examples: "MONTHS", "cm". | Exp |