We have prepared this resource hub with best practices, tips and tricks and all the latest news so you can stay in the know about the EMA Clinical Trial Regulation (CTR) that goes into effect on 31 January 2022.
We will continue to update the hub as more information becomes available so check back often!Schedule a Consultation with Veeva Experts
What is CTR?
The EMA Clinical Trials Regulation (CTR) aims to create an environment that is favorable to conducting clinical trials in the European Union (EU)/European Economic Area (EEA), with the highest standards of safety for participants and increased transparency of trial information.
What is CTIS?
The regulation harmonises the assessment and supervision processes for clinical trials throughout Europe, via a Clinical Trials Information System (CTIS) – a centralised portal and database for clinical trials. CTIS is the entry point to submit all the required data for a clinical trial following CTR, and is the interface between Sponsors and Member States.