Feasibility Assessment of Using CDISC Data Standards for In Silico Medical Device Trials

Abstract

This report summarizes the current applicable regulatory framework and CDISC data standards for in vivo and in silico medical device randomized clinical trials, with an emphasis on transcatheter aortic valve replacement devices (TAVI). Trial Implementation issues and scenarios are discussed as well. This report has been prepared within the Horizon 2020 programme ‘In-Silico testing and validation of Cardiovascular IMplantable devices‘ (SIMCOR, GAID: 101017578) project and would be of relevance for clinical development, data management, and regulatory submission teams.