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The European Data Protection Board

Having regard to Article 70(1)(e) of Regulation 2016/679/EU of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC.

HAS ADOPTED THE FOLLOWING GUIDELINES

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EXECUTIVE SUMMARY

The concepts of controller, joint controller and processor play a crucial role in the application of the General Data Protection Regulation 2016/679 (GDPR), since they determine who shall be responsible for compliance with different data protection rules, and how data subjects can exercise their rights in practice. The precise meaning of these concepts and the criteria for their correct interpretation must be sufficiently clear and consistent throughout the European Economic Area (EEA).

The concepts of controller, joint controller and processor are functional concepts in that they aim to allocate responsibilities according to the actual roles of the parties and autonomous concepts in the sense that they should be interpreted mainly according to EU data protection law.

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On January 23, 2019, the EU Data Protection Board (“EDPB” – the gathering of all European Union (EU) data protection authorities) adopted opinion no. 3/2019 (the “Opinion”) on the interplay between the Clinical Trials Regulation no. 536/2014CTR”) and the General Data Protection Regulation (“GDPR”). Anticipating the application of CTR (currently expected to occur in 2020) following the implementation of the EU portal and the EU database of the European Medicines Agency, the Opinion provides clarification on (i) the different legal bases for the processing of personal data operations related to a specific clinical trial, from commencement of the clinical trial until the deletion of personal data collected during the clinical trial (“Primary Use”); and (ii) the further use of the same personal data set for any other scientific purposes (“Secondary Use”). Without establishing a legal basis, no one can process the personal data needed to run a clinical trial or to use the personal data for other research.

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