SDTM Device-in-Use (DU)

Description TOBA-688 - Getting issue details... STATUS

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.

du.xpt, Device-in-Use — Findings. One record per property or setting per time point per visit or test date per subject, Tabulation.

Specification

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

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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. 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	(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 (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	An assigned numeric identifier that aligns to the chronological order of an encounter. Numeric version of VISIT, used for sorting.	Exp
VISIT	Visit Name	Char		Timing	The label for a protocol-defined 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

Assumptions

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.
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.
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.
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.
This domain is not intended to capture manufacturer-set (i.e., nominal) settings, but rather the customized settings for a given usage.
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.
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).
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).
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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SDTM Device-in-Use (DU)