Description

A findings domain that contains the measurements and settings that are intentionally set on a device when it is in use. These are characteristics that exist for the device, and have a specific setting for a use instance.

Specification

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

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 NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore

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.

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.

Perm

DUSPID

Applicant-Defined Identifier

Char


Identifier

Applicant-defined reference number.

Perhaps pre-printed on the CRF as an explicit line identifier or defined in the applicant's operational database.

Perm

DUTESTCD

Device-In-Use Test Short Name

Char

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 (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

  1. An assigned numeric identifier that aligns to the chronological order of an encounter.
  2. Numeric version of VISIT, used for sorting.

Exp

VISIT

Visit Name

Char


Timing

  1. The label for a protocol-defined encounter.
  2. 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

Assumptions

  1. Definition: The Device In-Use (DU) domain represents properties of an ancillary device that are intentionally set when the device is used in the context of a study.
  2. Tobacco products—including ENDS devices—are not considered ancillary devices and would not be represented here. An ancillary device is a device used within a study but which is not the target of the study (e.g., a smoking machine that performs a smoking regimen or a spirometer used in pulmonary function testing). If settings for an ancillary device in a study need to be recorded and the device needs to be identified in the data, DI must be used for that identification.
  3. Unlike Device Properties (DO), which describes device characteristics that do not change for the device during the study, the DU domain captures characteristics and properties of a device that can vary from subject to subject or usage to usage over the course of a study. For example,
    1. The full range of field strengths for a given MRI machine might be 0.5 to 3 Tesla, and these values would be captured in DO. DU would record the specific settings used for a given subject (e.g., the field strength for the MRI scan for subject 123 was 0.5T for visit 1).
    2. The software for a pacemaker may start at Version 1, and be updated to Version 2 during the study. This change can be captured here. It would not go in DO, as DO holds only characteristics that do not change during the study.
  4. There are two primary identifiers in this domain: USUBJID and SPDEVID. Both are Expected. Either 1 or the other or both must be used. For example, a device under study will always have a SPDEVID, but may or may not have a USUBJID. An ancillary device (one not under study) for which in-use data are required may have a USUBJID but may or may not have SPDEVID. In all cases where SPDEVID is used, it must be defined in the Device Identifiers (DI) domain.
  5. This domain is not intended to capture manufacturer-set (i.e., nominal) settings, but rather the customized settings for a given usage.
  6. Because any number of device settings (e.g., coil strength, placement of leads) can be reported in this domain, each setting is represented by a separate row and is defined in the topic variable DUTESTCD. The original result goes into DUORRES.
  7. DUREFID is the identifier for a unique scan or other test result to link a group of settings (e.g., field strength or slice thickness in an MRI scan) to the results obtained from the reading or interpretation of the test (e.g., the MRI image).
  8. The DUSPID variable can be used to link this domain to other domains if necessary, such as Adverse Events (AE), Exposure (EX), and/or Tobacco Product Device Events and Malfunctions (EM).
  9. The following Qualifiers would not generally be used in DU: --MODIFY, --BODSYS, --POS,--ORNRLO, --ORNRHI, --STNRLO, --STNRHI, --STNRC, --NRIND, --RESCAT, --REASND, --XFN, --NAM, --LOINC, --SPEC, --SPCCND, --LOC, --METHOD, --FAST, --DRVFL, --EVAL, --TOX, --TOXGR, --SEV, --DTHREL, --LLOQ.

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