European Commission Directorate-General For Health And Food Safety: Question and Answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation
Is a sponsor established in [a] third country subject to EU data protection rules?
The GDPR applies to controllers and processors established in the EU as well as to controllers and processors not established in the EU where the processing activities are related to the offering of goods or services to data subjects in the EU or the monitoring of their behaviour in the EU (Article 3 GDPR).
Where the sponsor processes personal data of data subjects in the EU related to these purposes, including in the context of managing the clinical trial, the GDPR is fully applicable, including the obligation to designate a representative in the EU (Article 27 GDPR).
Download all questions and answers in the Florence Beginner’s Guide to GDPR for Clinical Trials.
The information presented in our library is for informational purposes only, they are not for implementation in operations. Please consult official GDPR guidance documents for operational use.
This information was sourced from the European Commission Directorate-General For Health And Food Safety: Question and Answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation.
