The Regulation (EU) No 536/2014 (Regulation on clinical trials, CTR)  aims to facilitate the conduct of clinical trials in Europe, while at the same time, preserving the highest standards of patient safety and transparency.

An EU platform and database developed for this purpose, namely the Clinical Trial Information System (CTIS), supports the implementation of the CTR. The wide range of tasks that CTIS is intended to perform is reflected in its buildup and its complex user structure.  

All applications for clinical trials with medicinal products throughout Europe are to be submitted and processed via CTIS and jointly assessed by the federal higher authorities and the ethics committees. 

To be able to meet the CTIS requirements and the stricter deadline management, the Ethics Committee of the Heidelberg Medical Faculty has, therefore, provided a CTIS manager and a CTR coordinator.

Their responsibility essentially comprises training employees in the use of the portal and providing support in the event of any problems, monitoring the deadline management, and harmonizing the workflow between the Ethics Committee and the federal higher authorities.