Publication of clinical trial results is a fundamental element of transparency and public trust in clinical research. Regulation (EU) No 536/2014 (CTR) establishes clear requirements for the sponsors to submit a summary of trial results, accompanied by a layperson summary, to CTIS within the applicable timelines following the end of the clinical trial in all Member States concerned.
Article 37 CTR requires sponsors to submit the summary of results of the clinical trial and the layperson summary in the content and format required by Annexes IV and V of the CTR. Primary responsibility for the timely submission, the completeness and accuracy of these documents lies with the sponsor.
The European Medicines Regulatory Network remains committed to supporting the effective implementation of the requiremetns under Article 37 CTR regarding submission of a summary of the results. Moreover, CTIS provides sponsors with in-system notices and deadline reminders, which are since very recently supplemented by direct email notifications. The sponsor handbook has been revised with detailed guidance on results submission.
Bulgaria supports the timely and transparent publication of clinical trial results through CTIS and encourages sponsors to submit timely, complete and accurate scientific and layperson summaries of the results of the clinical trial in accordance with Article 37 of Regulation (EU) No 536/2014.
Further information may be found on EudraLex Volume 10 “Clinical trials Regulation (EU) NO 536/2014 Questions & Answers” on the following link:
