On January 23, 2019, the European Data Protection Board (EDPB), released an opinion on the relationship between the European Clinical Trials Regulation (CTR) and the EU General Data Protection Regulation (GDPR) (the “Opinion”). The CTR, scheduled to take effect in 2020, is designed to harmonize how clinical trials are assessed and supervised across the EU. It introduces a Clinical Trials Information System and establishes rules that protect individuals and enhance transparency requirements. In its Opinion, the EDPB provides guidance on (1) the legal bases for primary uses of clinical data, i.e., processing personal data in the course of a clinical trial protocol, and (2) secondary uses of clinical trial data…