Clinical Trials Regulation & CTIS
Clinical Trials Regulation & CTIS
The way clinical trials are conducted in the European Union (EU) has undergone a major change when the Clinical Trials Regulation (Regulation (EU) No 536/2014) came into application on 31 January 2022. The Regulation harmonises the submission, assessment and supervision processes for clinical trials in the EU through the Clinical Trials Information System (CTIS).
CTIS is the single entry point for submitting clinical trial information in the EU and the European Economic Area (EEA). CTIS contains a Sponsor workspace for clinical trial sponsors and the organisations that work with them, an Authority workspace for EU Member States, EEA countries and the European Commission, and a public website.
- The Sponsor secure workspace assists clinical trial sponsors in preparing and compiling the clinical trial application and related documents to submit for assessment.
- The Authority secure workspace supports the activities of EU Member States, EEA countries and the European Commission in assessing and overseeing clinical trials.
- Through the public website, members of the public can access detailed information on all clinical trials conducted in the EU and the EEA once trials start to be submitted and approved in CTIS.
EU Member States and EEA countries assess and supervise clinical trials in CTIS, while EMA sets up and maintains CTIS. The European Commission ensures the correct interpretation and implementation of the Clinical Trials Regulation.
The Clinical Trials Regulation foresees a 3-year transition period to CTIS.
- From 31 January 2022 until 30 January 2023 at 16:15, clinical trial sponsors can choose to submit their clinical trial applications under the Clinical Trials Directive (EC) No. 2001/20/EC through national submission processes, or under the Clinical Trials Regulation through CTIS.
- From 31 January 2023 all new clinical trial applications in the EU and EEA must be submitted under the Clinical Trials Regulation through CTIS.
- From 31 January 2025 trials approved under the Clinical Trials Directive that are still ongoing will have to be transferred to the Clinical Trials Regulation and to CTIS.
EU Member States and EEA countries will have to work in CTIS from go-live, once applications are submitted.
How clinical trials are processed in CTIS
Clinical trial sponsors who want to gain regulatory approval for a clinical trial in one or more EU Member States and EEA countries submit a single clinical trial application form and supporting dossier through CTIS. The submission of the single clinical trials application form and supporting dossier also includes the public registration of the clinical trial.
CTIS supports the day-to-day business processes of EU Member States, EEA countries and sponsors throughout the lifecycle of a clinical trial. It provides regulatory oversight of clinical trials and tools for supervision and monitoring.
How to register for CTIS
Clinical trial sponsors that want to use CTIS must ensure their users have an EMA account. Users that have already an EMA account, for example to use Eudravigilance or the substances, products, organisations and referentials database (SPOR) do not need to create a new account. Users that do not have an EMA account can register via EMA Account Management.
Clinical trial sponsors may need to complete additional registration steps based on the user management approach they choose for CTIS. The organisation-centric approach allows for the management of users by an administrator at the organisation level rather than at the level of an individual trial. It is intended for organisations that will run several trials in CTIS. To make use of the organisation-centric approach, organisations must ensure they are registered in EMA’s Organisation Management System (OMS), and they must register a CTIS High Level Administrator via EMA Account Management.
How to prepare for CTIS
Clinical trial sponsors can consult the CTIS Sponsor Handbook for guidance on how to prepare for CTIS.
In addition, clinical trial sponsors can use the CTIS online training programme. The guide to the CTIS training material catalogue, which can be found on the training programme page on the EMA website, provides an overview of the training programme.
On the Clinical Trials-website there is the CTIS log in-page (in the top right coner).
More information on CTIS can be found on the EMA Website.
For more information on training and support for the use of CTIS is available on EMA's CTIS training and support page.
EMA's modular training program page contains information and training on the functionalities of CTIS.
More information on the Clinical Trials Regulation, visit Eudralex – Volume 10 – clinical trials guidelines.
Questions on CTIS functionalities can be directed through the CTIS User Support Service.