Other news on clinical trials
date: 13/02/2024
- FAQs on how to create, submit and withdraw a Clinical Trial Application (module 10 of CTIS training programme) with new questions on medical devices, partial submission applications and other types of CT applications (substantial modification, additional Member State concerned);
- European Commission Clinical Trials Regulation Questions & Answers document with new questions on the definition of inpatient hospitalisation, Annual Safety Report format for non-commercial sponsors running a single clinical trial with an authorised investigational medicinal product, and preferred language for the ASR in Member States.