This is the News

The CDISC-AdvaMed Device Team has covered a lot of ground since the last CDISC newsletter update.  As many of you are aware, this project seeks to develop in parallel the CDASH data collection fields, the SDTM submission variables and the associated metadata for basic device clinical studies. 

The SDTM side of the project has explored and identified the differences in device data and use cases for diagnostics, implantable devices and imaging devices.  Based on this, the team has identified the need for 4 new implantable device SDTM domains that will be developed in Device Package 1.  Those for diagnostics and imaging devices will follow later.  

The new domains are:

1. Device Disposition: links a specific device to a specific subject
2. Device Tracking: tracks the movement of the device between sponsor and site and, if necessary, the site and the subject.
3. Device Properties: describes the characteristics of a device at the generic or model level (possibly also each component of a device)
4. Device Malfunctions: records the malfunctions of a specific device

In addition, further device elements have been identified for the following domains: Device Identification, Demographics, Drug Accountability, Subject Exposure and Subject Disposition.  These domains will be included in Device Package-2 that will be developed later in 2010.

In parallel, the CDASH collection fields are being identified to accompany these 4 new SDTM domains. The goal is to focus on the basic device data collection fields that are seen in the majority of device clinical trials. To achieve this goal, a CRF-Analysis sub-team was formed.  This group collected and reviewed ~ 170 device CRFs from 42 device companies to identify areas where devices differ from or are the same as drug studies. Interestingly, the results of this analysis reveal that the current CDASH domains and collection fields developed for drug trials meet almost all the requirements of medical device trials. The team is also looking at existing Controlled Terminology to identify any gaps that may require the development of device specific terminology.  Once this gap analysis is completed new terms will be requested according the terminology change control process located on the NCI EVS webpage.

The Team is now working to prepare the “initial consensus version” (ICV) that will include both the new SDTM and CDASH device-related domains and to begin the first review period described in the CDISC consensus process. This consensus process includes an internal CDISC review and an external focused review followed by an open public review period. Comments from each of these review cycles will be addressed prior to the release of the final standard.

The overall goal is for the new CDASH and SDTM device domains to be incorporated into a device standard by Q2 2010.

For further information about what Device team is doing, please contact:

Rhonda Facile, Carey Smoak, Kit Howard or Fred Wood.