November 2019: EU Clinical Trial Regulation Update

On Nov 7, the EC published an updated Draft Questions and Answers Document (Version 2.2) (Eudralex Volume 10 – Clinical trials guidelines – Set of documents applicable to clinical trials under Regulation EU No 536/2014)

Q&As that were added or revised include, 1.6, 2.2, 2.7 (NEW), 2.8 (NEW), 3.3 (NEW), 6.2:

  • THE SCOPE OF CLINICAL TRIALS REGULATION IN THE EU — 1.6 Is the definition of ‘medicinal product’ relevant for the scope of the Clinical Trials Regulation?
  • APPLICATIONS LIMITED TO PART I  — 2.8 Will the assessment report on part I and II be made public at the time of decision?
  • SUBSTANTIAL MODIFICATIONS — 3.3 What are the sponsor’s responsibilities regarding changes to a clinical trial which are not substantial modifications (SM), but are relevant for the supervision of the trial (Art. 81.9)?
  • SUBMISSION OF RESULTS OF CLINICAL TRIALS — 6.2: Which endpoints need to be summarized in the lay summary of results of a clinical trial?

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