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GDPR for Information Transfer to Clinical Trial ParticipantsBlake Adams2024-02-16T17:16:36-05:00

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

How to understand the requirements of the GDPR regarding information that should be given to subjects participating in a clinical trial?

Any person included in a clinical trial should receive the relevant information related to the clinical trial as required by the CTR as well as the information according to Article 13 of the GDPR, in particular the legal basis for data processing (see Q&A 3).

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The information presented in our library is for informational purposes only, they are not for implementation in operations.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.

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Download the Beginner’s Guide to Global Data Protection Regulation (GDPR) for Clinical Trials

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