| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|
STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
DOMAIN | Domain Abbreviation | Char | DU | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char |
| Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Expected in this domain as devices may have settings or uses that either may not involve subjects (e.g., diagnostic tools) or devices that are removed from the study prior to contact with a subject (e.g., device has malfunction). | Exp |
SPDEVID | Applicant Device Identifier | Char |
| Identifier | Applicant-defined identifier for the device. The value of SPDEVID may be linked to a nonclinical trial set by a matching value of the parameter APDEVID in the TX dataset. 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, or combination of identifiers). | Exp |
DUSEQ | 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 |
DUGRPID | Group ID | Char |
| Identifier | Identifier for a group or block of related records. Used to tie together a block of related records in a single domain for a subject or a group of subject related records (e.g., group records specifying all the settings for a specific imaging scan, such as field strength, repetition time and echo time). | Perm |
DUREFID | Reference ID | Char |
| Identifier | Internal or external identifier. This could be a scan code or equivalent.
The value of DUREFID may be linked to a nonclinical trial set by a matching value of the parameter SMKRGM. SMKRGM is an identifier used to represent a smoking regimen in the TX dataset and serves as a link to the Device-In-Use (DU) domain, where a matching value of DUREFID indicates parameters of the smoking regimen performed by the smoking machine. | Perm |
DUSPID
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STATUS
| Applicant-Defined Identifier | Char |
| Identifier | Applicant-defined reference number. | Perm |
DUTESTCD | Device-In-Use Test Short Name | Char | (DUTESTCD) | Topic | Short name of the measurement, test, or examination described in DUTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in DUTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST"). DUTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "COILSTR", "CNTMEDIA". | Req |
DUTEST | Device-In-Use Test Name | Char | (DUTEST) | Synonym Qualifier | Verbatim name of the test or examination used to obtain the measurement or finding. The value in DUTEST cannot be longer than 40 characters. Examples: "Coil Strength", "Contrast Media". | Req |
DUCAT | Category for Device-In-Use | Char |
| Grouping Qualifier | Defines a category of related records. It can be used to define the type of device for which settings are recorded if the DI domain is not used
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STATUS
(e.g., if the device is not under study); may also be used to record the type of setting (e.g., "HARDWARE" vs. "SOFTWARE"). | Perm |
DUSCAT | Subcategory for Device-In-Use | Char |
| Grouping Qualifier | A further categorization of a measurement or examination. For example, if DUCAT = "SOFTWARE", DUSCAT might be "NOMINAL" or "POST-ADJUSTMENT". | Perm |
DUORRES | Result or Finding in Original Units | Char |
| Result Qualifier | Result of the measurement as originally received or collected. DUORRES should contain the setting or other device condition in effect at the time the device was used. | Exp |
DUORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original units in which the data were collected. The unit for DUORRES. Examples: Tesla, mm. | Exp |
DUSTRESC | Result or Finding in Standard Format | Char |
| Result Qualifier | Contains the result value for all findings, copied or derived from DUORRES in a standard format or standard units. DUSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in DUSTRESN. For example, if a test has results "NONE," "NEG," and "NEGATIVE" in DUORRES, and these results effectively have the same meaning, they could be represented in standard format in DUSTRESC as "NEGATIVE". | Exp |
DUSTRESN | Numeric Result/Finding in Standard Units | Num |
| Result Qualifier | Used for continuous or numeric results or findings in standard format. Copied in numeric format from DUSTRESC. DUSTRESN should store all numeric test results or findings. | Exp |
DUSTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized unit used for DUSTRESC and DUSTRESN. The unit for standardized results may or may not be the same as for the original results. | Exp |
VISITNUM | Visit Number | Num |
| Timing | A clinical encounter number. A Numeric version of VISIT, used for sorting. | Exp |
VISIT | Visit Name | Char |
| Timing | Protocol-defined description of clinical encounter. May be used in addition to VISITNUM and/or VISITDY. | Perm |
VISITDY | Planned Study Day of Visit | Num |
| Timing | Planned study day of the visit based upon RFSTDTC in Demographics. This value is usually derived. | Perm |
DUDTC | Date/Time Device Used with Test/Setting | Char | ISO 8601 datetime or interval | Timing | Date/time that the device was used with this setting. This is not the date/time that the setting was set on the device, but rather that date/time that a measurement or test was done using that setting. | Exp |
DUDY | Study Day of Observation | Num |
| Timing | Study day of Device-In-Use measurement, measured as integer days. Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. | Perm |