Update - EudraLex - Volume 10 - Clinical trials guidelines - Questions and Answers Document - Regulation (EU) 536/2014 – Version 6.2 (September 2022)

On 26 September 2022 the European Commission published the updated Q&A document on clinical trials regulation EU 536/2014, version 6.2.

The aim of this document is to provide general guidance on the implementation of the CTR. This document 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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