European Commission Publishes Quick Guide for Sponsors on Clinical Trials Regulation
The European Commission published yesterday in EudraLex (Volume 10) the first edition of a quick guide for sponsors on the rules and procedures of the Clinical Trials Regulation (Regulation (EU) No 536/2014; CTR) (see, attached copy; the Guide). The Guide was developed by the Clinical Trials Coordination and Advisory Group (CTAG), which is an HMA (Heads of Medicines) working group of experts in the classification, assessment and oversight of clinical trials from national medicines agencies.
The Guide aims to facilitate the implementation of the CTR and is structured along the different steps involved in a clinical trial (steps before the start of the trial, steps during the trial and steps after the trial has ended) (see, sections 2, 3 and 4). Further, the Guide discusses some transparency-related matters, in particular the protection of commercially confidential information and of personal data (see, section 5). It concludes by (i) highlighting the particularities of clinical trials on Advanced Therapy Medicinal Products; and (ii) listing some relevant guidance documents, recommendation papers and Q&As which cannot be found in EudraLex (see, section 6).
The Guide emphasises that it should be read in combination with the CTR which, ultimately, can only be interpreted authoritatively by the Court of Justice of the European Union.