“Where the sponsor processes personal data of data subjects in the EU, including in the context of managing the clinical trial, GDPR is fully applicable, including the obligation to designate a representative in the EU.”

The European Commission has updated FAQs on the interplay between the forthcoming Clinical Trials Regulation (CTR) and GDPR.

Key Takeaways:

Clinical trials and the EU General Data Protection Regulation (GDPR): The European Data Protection Board (EDPB) has issued a much-awaited opinion on the legal basis for processing clinical trial data.

Key takeaways:

  • The legal basis for processing operations expressly provided by the Clinical Trial Regulation and by relevant national provisions, as related to reliability and