Questions and Answers - Complex Clinical Trials

2 June 2022 — European Commission published updated Q&A guidance on complex clinical trials, version 2022-05-23.

This Q&A document provides guidance and seeks to support sponsors, clinical trialists and applicants regarding scientific aspects and the planning, set-up, submission for obtaining CT authorization (CTA), conduct, reporting and transparency, analysis and interpretation of complex clinical trials (CCTs) under the EU Clinical Trials Regulation (EU CTR) as well as their use in submissions for marketing authorization.

Read more online 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /