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changes.mady.by.user Lou Ann Kramer

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  1. Definition: Device Properties (DO) is a Findings domain and defines important characteristics of a device that the applicant wishes to include in the submission but that do not form part of the unique applicant-defined identification of the device. If there are no non-identifier characteristics to submit, this domain may not be necessary.
  2. Each property is identified using controlled terminology and is stored in DOTESTCD/DOTEST, which allows the property names to be values in DOTESTCD in an SDTM-based vertical (normalized) structure and variable names in a CDASH horizontal (non-normalized) structure, if necessary. The controlled terminology has not yet been identified.
  3. There should be one 1 record per device property.
  4. Applicants define the properties and levels of granularity that are appropriate to include in this domain.
  5. DO supports all device types (e.g., implantable, imaging, diagnostic), although implementation may vary by device type.
  6. This domain does not define the relationships between tracked components and the overall device. This will be addressed in a future version of the standard.
  7. DO should not contain characteristics that may change during the course of the study for a given device (e.g., dial settings on an imaging machine, software versions). As a result, the domain does not include Timing variables (SDTM Table 2.2.5).
  8. Applicants may choose whether to include in DO characteristics of approved products or components that are used in the study in accordance with the approved labeling.
  9. The DO domain can contain data about devices that were not deployed, as there is no subject identifier in DO. It should contain only data that should be submitted with the clinical data; additional manufacturing and quality data may exist elsewhere in the submission and do not need to be included in DO unless the applicant has a specific reason to do so.
  10. DO data would generally be assembled by a applicant, rather than by an investigative site. The data can be captured using a CRF, assembled on a worksheet to support entry of the information into the clinical database, derived manually, or derived electronically from data in other domains or elsewhere.
  11. DOTESTCD values are limited to 8 characters and cannot begin with a number or underscore as they can be used as variable names when the dataset is transposed to a non-normalized structure.
  12. Note that there are no examples currently included in the Tobacco Implementation Guide TIG for this domain.