Processing and cross-border flows of personal data significantly increased over the past decades in the EU, and it became necessary to strengthen the associated legislation. This led the European Commission to adopt the General Data Protection Regulation (GDPR (Regulation (EU) 2016/679) to protect the fundamental right of citizens to privacy with respect to the processing of their personal data, while not restricting nor prohibiting the free flow of personal data in the EU. In this article, an overview of the GDPR contributions in the framework of clinical trials in the EU, including its impact on patients’ rights, sponsors responsibilities, and patient information leaflet informed consent form, is provided.
In addition, EU citizens’ perceptions and expectations about data protection and the impact of the GDPR are discussed. Finally, the limits of the GDPR and more particularly the exemptions/derogations to patients’ rights are described.