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  1. Medical Devices Home on the CDISC Portal
  2. Medical Devices Home on the CDISC Wiki (Access may be restricted to Medical Devices Team Members)
  3. 2015 CDISC Technical Plan

Leadership Team

  • Kit Howard (CDISC)
  • Carey Smoak (Portola)
  • Fred Wood (Accenture)

Additional Key Contributors

The Device team includes representatives from other CDISC Foundational Teams and a set of subteams representing different facets of the CDISC Device standards.

Other key contributors include:

  • Paul Franson, Medtronic
  • Bernice Yost, CDISC
  • Priya Gopal, Theorem Clinical
  • Julia Yang,  Medtronic
  • Mike Yu, St. Jude Medical
  • Minghua Grissel, W. L. Gore
  • Henry Friend II, Abbott Diabetes
  • Rose Grandy, Abbott
  • Mike Waters, CDRH
  • Denise Desmond, Shire
  • Charlotte Patterson, Parexel



 

Team Mission

To define data collection, submission and analysis standards for research involving  medical devices.

Scope

This project is developing collection (CDASH), submission (SDTM) and analysis (ADaM) standards with associated controlled terminology to support electronic submission of PMAs, 510(k)s and Biologics License Applications (BLAs).  It also supports implementation of CDISC standards for drug/device combination products, and the use of devices in non-device studies (e.g., Therapeutic Area studies).

Stakeholders/Constituency

  • Regulatory Authorities
  • Standards Development Organizations
  • Pharmaceutical Sponsors
  • Medical Devices, Diagnostics companies
  • Contract Research Organizations, Technology Vendors & Consultants
  • Other organizations conducting or supporting device-related research (e.g., universities)

Collaborations

SDTM, CDASH, ADaM, NCI EVS, Therapeutic Area Teams, FDA (CDRH)

Operating Model & Meetings

The full Device Team meets monthly on the third Thursday of each month at 1 pm EST.

The Device leadership team meets the first Thursday of each month at 1 pm EST.

Sub-teams meet monthly, bi-weekly or weekly as needed. The sub-teams are:

  • CDASH/CRF
  • Controlled Terminology
  • Diagnostics domains
  • ADaM
  • Granularity & Components
  • Training

Project documents are stored on the CDISC team portal located here: www.portal.cdisc.org/Teams%20Projects/DEVICES/

Documents are migrating to the CDISC Wiki at Medical Devices Home