The conduct of clinical trials in countries of the EEA will change significantly since the regulation on clinical trials entered into force on 31 January 2022.
From this time on, it will only be possible to apply for authorization for clinical trials in CTIS. The CTIS will contain secure workspace for clinical research sponsors and institutions working with them, secure workspace for EEA Member States, the European Commission, and an official website. At the sponsor‘s workspace, they will be able to compile an application for clinical trials and submit relevant documentation in connection with the application.
- At the sponsor‘s workspace, they will be able to compile an application for clinical trials and submit relevant documentation in connection with the application.
- On the EEA Member State and European Commission workspace it will be possible to evaluate and monitor clinical trials.
- On the CTIS official website, the public can access detailed information on all clinical trials conducted in the EEA, from the time data were submitted and (later) processed in the CTIS system.
Transition period
The European Regulation on Clinical Trials provides for a three year transition period for transfers to the CTIS system.
- From 31 January 2022 to 31 January 2023, sponsors of clinical trials may choose to submit their application in accordance with the old rules, the Clinical Trials Directive, in accordance with the application rules in each country or submit applications through the CTIS system in accordance with regulations.
- From 31 January 2023, all new applications for clinical trials in the EEA contries must be submitted to the CTIS system in accordance with the relevant regulations.
- Studies that have been approved under the aforementioned Clinical Trials Diretive, and are not expected to be completed by 31 January 2025, need to be transferred to the CTIS system before that time.
After the CTIS information system has been implemented and applications have been submitted, all data must be processed within the system.
Management and processing of data in CTIS
Sponsors who apply for authorization to perform a clinical trial in one or more EEA Member States will only be required to submit one application together with supporting documents through CTIS. Submitted data will also be considered as public registration.
CTIS is a foundation where the clinical trial process is followed from beginning to the end. The portal ensures transparency and overview and acts as a tool for monitoring.
How to register in CTIS?
In order to use CTIS it is necessary to have access to the EMA website. Users who already have access do not need new access. Those who do not have EMA access can register through the EMA access control. Organizations may need to complete additional registration, depending on the access control selected for the CTIS system. The structure of the system is structured in such a way that the administrator supervises users rather than supervising individual tests. The portal is intended for organizations that will conduct more than one CTIS study. This requires registration in the Organization Management System (OMS) of the EMA, as well as the access of the CTIS administrator through the EMA access control.