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EU Clarifies Interplay Between CTR And GDPR

 
• By Vibha Sharma

A Q&A document from the European Commission elaborates on alternative legal bases, other than informed consent, for processing clinical trial data under the General Data Protection Regulation.

GDPR
EU Document Gives Clinical Trial Researchers More Clarity On GDPR • Source: Shutterstock

The European Commission's much-awaited question-and-answer document on the interplay between the Clinical Trial Regulation and the General Data Protection Regulation clarifies that informed consent obtained under both these legislative instruments serves different purposes.

Informed consent under the CTR must not be confused with consent as a legal ground for processing personal data under the GDPR, the commission states in the Q&A document published...

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