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 authorisation (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 authorisation. It complements and should be used together with relevant EU and ICH guidelines, in particular E6, E8, E9, E10, E16, E19, E11A and E20 (when available).
For the purpose of this document, the nomenclature follows the EU CTR, relevant ICH guidance, CTFG Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials (2019) and international common use as appropriate. Additional non-binding terminology conventions are described in the glossary to facilitate alignment between different sources of information and ensure consistent meaning…
