Questions and Answers Document – Regulation (EU) 536/2014

On 13 April 2022 the European Commission published Q&A guidance on Clinical Trials Regulation (EU) 536/2014, version 6.

This document aims at informing on the technical aspects of Commission Clinical Trials Regulation (EU) No 356/2014 with a view to facilitating its implementation. It sets out frequently-asked 'questions and answers' regarding the implementation of the rules on clinical trials. All updates to this questions and answers document are presented and discussed within the “Expert group on clinical trials” and reflects the view of the group. This group is chaired by the Commission and is composed of representatives of all EU Member States and EEA contracting parties.

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