Although the EU Clinical Trials Regulation (CTR) was adopted in 2014, its full application has been hampered by issues signing off the EU portal and database for clinical trials, also known as the Clinical Trials Information System (CTIS). Following an independent audit of the new system that was completed earlier this year, the European Commission has confirmed that 31 January 2022 will be the date of entry into application of the CTR, and the go-live of the CTIS.
The CTR was designed to create a harmonised environment for clinical trials conducted in the EU, aiming to guarantee the safety of participants and increasing transparency of information about clinical trials. A cornerstone of the CTR is the CTIS, an online portal which will act as a single EU entry point for clinical trial applications, and for monitoring of clinical trials during their life cycle.
The CTIS will allow sponsors to submit a single application for clinical trials based in multiple EU/EEA countries, cutting down on paperwork and administrative burden. The application will then be transferred to national competent authorities and ethics committees for each country involved. In creating the CTIS, the EU hopes to facilitate recruitment of participants across the EU/EEA, and enable greater sharing of knowledge, resources and data between stakeholders. The system will also include a public area where people can access information on all clinical trials conducted in the EU and their outcomes. More information on the CTR and CTIS can be found here:
