The document sets out frequently asked questions and their respective answers regarding the implementation of the rules on clinical trials. All updates to the questions and answers document are presented and discussed within the “Expert group on clinical trials” and reflects the view of the group.
In this article, the main topics of the document will be pointed out. If you are further interested in any one of them, please feel free to find the attachment for all related details.
1. The scope of clinical trials regulation in the EU, including comparison of Regulation (EU) No. 536/2014 and Directive 2001/20/EC.
2. Applications, including how to submit an application and the option to appeal against a decision.
3. Substantial modifications, including the definition and the related responsibilities.
4. Withdrawals, including the circumstances in which a sponsor is allowed to withdraw and the possibility of re-submission.
5. Sponsor/Legal representative, investigator, including the definition and the corresponding responsibilities.
6. Submission of results of clinical trials, including which endpoints need to be summarized.
7. Safety reporting, including the definition of an adverse event and what should be taken into consideration.
8. Authorization of manufacturing and importation of IMPs (investigational medicinal product).
9. “Informed Consent” and other substantial requirements for conducting clinical trials.
10. Start, end, temporary halt, and early termination of a clinical trial.
11. Arrangements for the transitional period.
Attachment: Clinical trials guidelines - Questions and Answers Document - Regulation (EU) 5362014 – Version 6.2