Clinical Trials Information System (CTIS)

What is CTIS?

CTIS is a shared European online portal for clinical trials. All clinical trials conducted within the EU and EEA area must be applied for via CTIS. 

CTIS consists of a workspace for sponsors and applicants, as well as a workspace for national competent authorities and ethics committees. There is also a public website, accessible to members of the public. 

The sponsor workspace in CTIS is used for submitting applications for clinical trials (the initial application and substantial modification) and for reporting throughout the lifecycle of the clinical trial.  

The authority’s workspace in CTIS facilitates the activities of national competent authorities and ethics committees, including, among other tasks, the assessment of applications and the oversight of clinical trials. Please note that all communication between sponsors and authorities will take place within CTIS. 

Through CTIS's public website, the general public can access information about clinical trials conducted in the EU/EEA. Information about a clinical trial is published as soon as it receives a decision in CTIS.

Processing of Clinical Trial Applications in CTIS

All clinical trials conducted within the EU/EEA area must be applied for via CTIS. Applicants will also receive responses to their applications in CTIS. This means that all correspondence regarding the application will take place within the system, and sponsors must therefore be mindful of deadlines and receipt of responses. 

It is the sponsor/applicant's responsibility to monitor deadlines in CTIS and submit responses to Request For Information (RFI) on time. If questions are not answered or are insufficiently addressed, the application may lapse or be rejected. Please note that CTIS does not send email notifications to applicants. 

If a trial is to be conducted in multiple countries, the authorities in the affected countries will collaborate on the evaluation of the study. At the national level, the Norwegian Medicinal Products Agency (NOMA) and the Ethics Committees (REK KULMU) will coordinate a joint decision for Norway. 

CTIS is used throughout the entire lifecycle of the clinical trial, for example, applications for substantial modifications, notifications i.e. reporting study initiation or completion, annual safety reports, incidents, etc. 

How to access CTIS

To access CTIS, you must first create an EMA account. Users who already have an EMA account, for example, to use the adverse reaction database EudraVigilance system or the database for substances, products, organizations, and reference data (SPOR), do not need to create a new account. Users who do not already have an EMA account can register via EMA Account Management. 

User Management Approach

Sponsors of clinical trials must decide which type of organisational approach they will use in CTIS: 

The "Organisation-centric approach" is designed for organisations managing multiple clinical trials in CTIS. These organisations must register a CTIS "High Level Administrator" via EMA Account Management. The High-Level Administrator manages the organisation's users in CTIS and assigns them various user roles. By adopting an "Organisation-centric approach," organisations can gain an overview and control of the clinical trials conducted within the organisation and enable specific users to handle different stages for one or more clinical trials. Examples include creating the initial application, responding to requests from authorities, or submitting annual safety reports. The High-Level Administrator can create users with different roles for the organisation as a whole, as well as for specific applications. The latter can, for example, be used to grant users from a CRO the ability to act on behalf of the sponsor regarding one or more trials. 

Alternatively, the sponsor can choose a "CT-centric approach," which is intended for smaller organisations, particularly academic sponsors managing a limited number of clinical trials. With this approach, there is no High-Level Administrator; instead, the user who creates the application for a clinical trial assumes the role of "Clinical Trial Administrator (CT Admin)". 

Online Training Modules and other Training Materials

CTIS training materials and an online training program can be found on EMAs webpage for CTIS: Training and support.

On the webpage you will find online training modules and support for both sponsors and national competent authorities. EMA has created a guide (Guide to CTIS training material catalogue) that outlines the different stages in the lifecycle of a clinical trial and the relevant training modules for each stage. This guide also covers the preparatory steps needed to use CTIS, such as user registration. 

Each module contains a summary of the topics it covers, including training materials. Training materials may consist of e-learning courses, quick guides, step-by-step guides, infographics, videos, frequently asked questions (FAQs), and instructor guides. 

Training Materials for Sponsors

To get started with CTIS, EMA has created a quick guide for Sponsors, see “Getting started with CTIS: Sponsor quick guide”. 

EMA has also developed a handbook for sponsors (Clinical Trial Information System (CTIS) – Sponsor handbook), which covers key topics identified by sponsors, with references and links to additional support materials. This CTIS Sponsor Handbook is updated as needed. 

Timelines and Deadlines

EMA has created an overview of timelines and deadlines for tasks and actions related to the various application processes in CTIS (Clinical Trial Information System (CTIS) evaluation timelines). This overview is useful for sponsors and illustrates how the dynamic workflow operates.

Additional Reference Materials

Additional reference materials are available on EMA’s website to support sponsors with various aspects of CTIS. These resources cover everything from getting started with the system to detailed information about organisational models and guidance on completing data fields in CTIS applications. The materials are updated periodically to ensure accuracy and relevance.

Training Courses and Events

EMA offers training courses for sponsors, including “walk-in” clinics and structured training sessions. For more information on dates and registration, please visit the EMA website.

More Information about CTIS

Clinical Trials Information System (CTIS) - Sponsor handbook
CTIS Newsletter