Use of Clinical Trials Information System (CTIS) Now Mandatory
Published 31st January 2023
The use of The CTIS is now mandatory for all initial clinical trial applications in the European Union (EU), as of the 31st January 2023.
Following the launch of The CTIS on 31st January 2022, the one-year transition period for all sponsors has now come to an end.
During the transition period, sponsors have been able to choose whether to submit an initial clinical trial application in line with the Clinical Trials Directive or under the Clinical Trials Regulation (CTR), via The CTIS.
What is the CTIS?
The CTIS facilitates interactions between sponsors (researchers or companies that run a clinical trial and collect and analyse the data) and regulatory authorities in the EU Member States and EEA countries, throughout the lifecycle of a clinical trial.
The European Medicines Agency (EMA) manages The CTIS and the public website in collaboration with European Union (EU) Member States, EEA nations, and the European Commission.
Anybody can view information held in CTIS on clinical trials in the EU and EEA, by using the searchable public website.
The European Medicines Agency (EMA) is delivering an online training programme to help clinical trial sponsors, national competent authorities, ethics committees, European Commission and EMA staff with using the CTIS. The training programme consists of a number of modules. These cover the full lifecycle of submission, authorisation and supervision. Find out more here.
CTIS explained:
The key benefits of the CTIS include:
- Digitalisation & improved efficiency
- Increased transparency
- Enhanced patient safety
- Support to innovation and research
I full list of benefits with details from the EMA can be found here.
Unsure of how the new regulation affects you?
DLRC have a CTR task force that is led by our in-house expert. DLRC has experience working with small and large scale transformation, and has the skills required to guide you through this change. DLRC’s expertise span Gap Analysis, Training, Dossier Preparation, and SOP updates, to name a few.
For more information about CTIS and to find out how DLRC can help support you with clinical trials, contact our expert team via enquiries@dlrc.co.uk or use the links below.
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