WP 5 Structuring a European medical device clinical research network
Objective: Structuring a European network and hub for clinical research on medical device:
establishment of a hub coupled to centres / networks and connected to ECRIN and its network of European Correspondents
development and adaptation of common tools for clinical investigation on medical device: inventory of investigation centres, and networks, regulatory and ethical expertise, training toolkit, quality assurance and monitoring, directory of expertise and specifications for investigators and facilities for participation in clinical trials, and a methodology taskforce promoting standardised outcome measures
use this combined infrastructure to design and conduct multinational clinical studies on medical devices
