|
Volunteers Needed
The Clinical Data Interchange Standards Consortium (CDISC) has formed a Device Sub-Team for proposing a domain for device properties/characteristics (Device Properties, DP) that is based upon the SDTM. The creation of this domain will permit diagnostic/medical device companies to begin submitting at least some device data to CDRH and CBER in a standard format. Many domains modeled in the SDTM Implementation Guide will become applicable to device trials. The sub-team is seeking industry experts from the diagnostics industry (e.g., blood-screening assays), implantable devices (e.g., heart stents), and imaging, as well as FDA representatives from CDRH and CBER to be a part of this newly formed Device Sub-Team.
Two levels of volunteer participation is needed:
1) Participation in teleconferences every other week to help with proposing the new domains and completing other related work actions
2) Review the drafts created by the Device Sub-Team and provide feedback.
|
