Clinical Trials Information System (CTIS)

What is CTIS?

CTIS is the single-entry portal for submitting applications and interacting on clinical trials in the EU and EEA. CTIS consists of a workspace for sponsors and a workspace for national competent authorities and ethics committees, as well as a public website, accessible to patients, healthcare professionals, scientists, clinical research associations, media, and members of the public.

The sponsor workspace is accessible to commercial and non-commercial sponsors and is used for submitting applications for clinical trials and reporting throughout the lifecycle of the clinical trial.

The authority workspace is used by EU/EEA national competent authorities, ethics committees and supports their activities including assessing applications and supervising clinical trials, among others.

Through the public website, the public can access information about clinical trials being conducted in the EU/EEA as soon as the clinical trial is approved.
All communication between sponsors and the national competent authorities will take place in CTIS.

Processing of Clinical Trial Applications in CTIS

To apply for approval of a clinical trial in one or more EU/EEA countries, the sponsor must submit a clinical trial application form with accompanying documentation through the portal. Upon submission, the clinical trial will be registered in the public part of CTIS.

CTIS is a tool for EU/EEA countries and sponsors, used for ongoing tasks throughout the entire lifecycle of the clinical trial. CTIS will help regulatory authorities supervise clinical trials to ensure they are conducted in accordance with regulations.

How can I access CTIS?

To access CTIS, one must first create an EMA account. Users who already have this, for example, for using the EudraVigilance system (system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA)) or the SPOR data management services (data management services for substances, products, organisations and referentials  (SPOR), do not need to create a new account. Users who do not already have an EMA account can create one via EMAs Account Management platform.

User Management Approach

Sponsors of clinical trials must decide which type of user management approach they will choose to use in CTIS:
The "organisation-centric approach" means that user management is done at organisation level and is intended for organisations handling multiple clinical studies in CTIS. The organisation/sponsor must appoint a "High-Level Administrator" (they must have a previously registered user account) via EMAs Account Management platform.

The High-Level Administrator manages the organisation's users in CTIS and assigns them various user roles. By having an "organisation-centric approach," one has the possibility to have an overview and control over the clinical trials conducted within the organisation. This approach also allows for the possibility to have specific users handle different stages in a clinical trial application, for example creating the initial application, responding to requests for information from national competent authorities, or submitting annual safety reports. The High-Level Administrator can create users with various user roles for the organisation as a whole, but also for specific applications. The latter can, for example, be used to give users from a CRO the opportunity to act on behalf of the sponsor regarding one or several specific trials.

Alternatively, the sponsor can choose a "CT-centric approach". This approach is intended for smaller organisations, (with academic sponsors in mind) who manage a smaller number of clinical studies. For this approach, there is no High-Level Administrator, but the user who creates a clinical trial application also has 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 aquick guide for Sponsors, see “Getting started with CTIS: Sponsor quick guide”.

EMA has also created a handbook for sponsors,“Clinical Trial Information System (CTIS) – Sponsor handbook” that covers priority topics identified by sponsors, with references and links to further support material. The Handbook is aimed at pharmaceutical companies, contract research organisations (CROs), small and medium-sized enterprises (SMEs), academic sponsors and other organisations working on clinical trials. EMA updates the handbook on a regular basis.

Timelines and Deadlines

EMA has created an overview of timelines and deadlines for tasks and actions across the clinical trial application process in CTIS, see “Clinical Trial Information System (CTIS) evaluation timelines”. This overview provides a detailed explanation of the dynamic character of the workflow.

Other Reference Materials

For available reference materials please see EMAs website. The reference materials can assist sponsors with everything from getting started in CTIS to information about organisational models and guidance on the data fields when filling out an application in CTIS. Reference materials are updated on a regular basis. 

Training Courses and Events

EMA offers training courses for sponsors, both in the form of “walk-in" clinics and training courses. Please see EMAs website for further information on dates and registration for courses.

More Information about CTIS

Clinical Trials Information System (CTIS) - Sponsor handbook
CTIS Newsletter
EMAs website on CTIS training and support