Where Do We Stand on Patients’ Informed Consent Forms?
First Learnings After One Year of GDPR
I. Introduction
Since the implementation of the EU General Data Protection Regulation 2016/679 (GDPR), there has been a lot of discussion with respect to the appropriate legal basis for the processing of personal data in the context of clinical trials. The interplay between the GDPR and the Clinical Trials Regulation (CTR)1, expected to enter into force in 2020, is under the spotlight.
The GDPR became…
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