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  1. Definition: The Device In-Use (DU) domain represents properties of the study device or ancillary device that are intentionally set when the device is used in the context of a study.
  2. An “ancillary device” is a device used within a clinical study to collect subject data/information (device or human subject), but that is not the target of the study (e.g., an MRI or CT machine whose settings must be recorded in a clinical trial studying heart failure, as required in the protocol). 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 0.5 T 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 one 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. There are cases where settings on devices used in studies might be reported in Device Exposure (DX) or DU, such as when the settings are changed to affect an efficacy response. Applicants should confer with the appropriate regulatory authorities to determine where to submit this information
  6. This domain is not intended to capture manufacturer-set (i.e., nominal) settings, but rather the customized settings for a given usage.
  7. 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.
  8. 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).
  9. The DUSPID variable can be used to link this domain to other domains if necessary, such as Adverse Events (AE), Exposure, and/or Device Events.
  10. Note that in some of the examples that follow, variables that would be blank may have been dropped to conserve space. This does not mean that the variables cannot be used in the illustrated use case, merely that in the specific example they were not populated.
  11. 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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