The Trials That Lie Ahead: EDPB Opines on Interplay Between EU Clinical Trials Regulation and GDPR

There has been a lot of confusion in the past months on applying the General Data Protection Regulation (GDPR) to clinical trials. For example, the GDPR requires honoring specific individual rights such as notice, access and deletion. However, that seems to be at odds with a clinical trial sponsor’s desire not to interact directly with participants or know who they are because the sponsor only gets coded data from investigators or because the study is blinded. The European Commission has recognized the need for clarifications, and is preparing a Q&A on the interplay between the GDPR and Clinical Trials Regulation 536/2014 (CTR). Prior to releasing its Q&A (which has not yet been made public), the Commission has requested the European Data Protection Board (EDPB) to advise on the Q&A. The EDPB issued its opinion in that respect on January 23, 2019.

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