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:
Team MissionTo define data collection, submission and analysis standards for research involving medical devices.
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).
CollaborationsSDTM, 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:
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