With the entry into application of the European Union’s (EU) Clinical Trials Regulation (CTR)(1), an additional emphasis is put on data protection compliance during clinical trials. This article explains the interplay between the CTR and the existing EU data protection rules, followed by a high-level overview of key privacy compliance items that are impacted by the CTR. This article does not address any specific obligations that may be imposed by national laws.

Background

The CTR entered into application on 31 January 2022. It applies to all clinical trials conducted in the EU.(2) In layman terms, a clinical trial is a study performed to investigate the safety or efficacy of a medicine. For human medicines, these studies are carried out on human volunteers.(3)