On 31 January 2023, the use of the Clinical Trials Information System (CTIS) will become mandatory for new clinical trial applications (CTA). It will serve as the single-entry point for submission by sponsors and for regulatory assessment.
CTIS is the single entry point for clinical trials information in the European Union and in the European Economic Area. This includes a single clinical trial application dossier, covering clinical trial applications submitted to Member States. Also, it contains submission to the National Competent Authorities and the Ethics committees, and registration of the clinical trial in a public register; all in one integrated submission.
It is happening now after one year transition during applicants could choose between national procedures under the Clinical Trials Directive or using CTIS following the new Clinical Trials Regulation (CTR), which entered into application in January 2022. This is the second phase of the transition period that started with the entry of the new CTR:
- 31 Jan 2022. New CTR entered into application and CTIS go live.
- 31 Jan 2023. CTIS become mandatory. All initial clinical trial applications must be submitted through CTIS.
- 31 Jan 2025. All ongoing clinical trials must go through CTIS. This means that ongoing clinical trials that were submitted through Clinical Trials Directive before January 2023, will have to transfer to CTIS.
Access to CTIS
CTIS is hosted in a user-friendly website, https://euclinicaltrials.eu. This website supports the business processes of clinical trial sponsors and national regulators throughout the lifecycle of a clinical trial, via the secure Sponsor workspace and Authority workspace.
Sponsors, using their workspace, can apply for authorisation to run a clinical trial in up to 30 EEA countries via a single application. Thus, they can carry out tasks including liaising with national regulators while a trial is ongoing and recording the results of the trial.
In the other side, using the Authority workspace, national regulators can work together through the website on the assessment and authorisation of a clinical trial in several countries.
The general public can also visit this website and search clinical trials in the EU. Currently, the website contains limited information on individual clinical trials since its launch on 31 January 2023. It will gradually contain more information as sponsors and regulators use it to initiate and oversee clinical trials in the EU.
Trainings
The European Medicines Agency (EMA) is working closely with national competent authorities in the Member States and the European Commission to facilitate the change to the new system for sponsors and other stakeholders.
A lot of training and supporting materials are available from the EMA on how to use the CTIS, this training courses are tailored for clinical trials sponsors and staff of the EU Member States and other organisations who are using the system.
- Online training modules cover the various stages of a clinical trial as well as preparatory steps needed to use CTIS, such as user registration. You can consult the modular training programme here!
- Supporting materials for authorities and sponsors and other organization involved, that include reference materials, practical guidance and even a handbook for sponsors on how to use CTIS. Consult the different supporting materials here!
We hope you found this information interesting and useful, for more information about the Clinical Trials Information System you can also check the general EMA’s website here.
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