The European Data Protection Board (EDPB) recently adopted its opinion on the interplay between the Clinical Trials Regulation 536/2014 (CTR) and the General Data Protection Regulation 2016/679 (GDPR) (the opinion). The opinion was given at the request of the European Commission.
The CTR seeks to harmonise the rules for conducting clinical trials throughout the European Union, and the request for an opinion stemmed from an acknowledgement of the crucial interplay between these two pieces of EU legislation. The EDPB emphasised that interplay by clearing stating in the opinion that the CTR cannot be used as an exemption for compliance with the GDPR.
The opinion distinguishes between the primary use of data and the secondary use of data in clinical trials.