Guidance and Q&As

The Clinical Trials Information System (CTIS) supports the business processes of clinical trial sponsors and national regulators throughout the lifecycle of a clinical trial, via secure workspaces. On this page you will find some basic questions about the use of CTIS.

About CTIS

The Clinical Trials Information System (CTIS) is the online system for the regulatory submission, authorisation and supervision of clinical trials in the European Union and the European Economic Area.

You can find more information on CTIS on our About page

Sponsors must submit initial clinical trial applications from 31 January 2023 under the Clinical Trials Regulation through CTIS. In addition, sponsors must transfer any ongoing trials started under the Clinical Trials Directive to CTIS by 31 January 2025.

If you work for a Member State organisation, please check with your Member State Master Trainer about whether you should use CTIS.

The Clinical Trials Information System (CTIS) is structured in two restricted and secured workspaces (sponsor workspace and authority workspace) and a public website.

Access to the secured CTIS workspaces is possible for any user that has obtained a valid EMA account (for any application managed by the EMA, e.g. SPOR, IRIS, EudraVigilance). If users do not have an EMA account, they will have to register through the self-registration process described below.

The sponsor workspace is accessible to sponsor users (industry and academia) and marketing authorisation applicants. The authority workspace is accessible to Member States' national competent authorities, ethics committees, the European Commission, and the European Medicines Agency (EMA). Access to the public website is possible for any user without the need for registration.

Register your organisation

If your organisation is registered in EMA’s Organisation Management Service (OMS), you can retrieve its details in CTIS to populate applications for clinical trials or your personal profile. If your organisation is not registered yet in the OMS, you should register it via the SPOR data management services first.

Guidance is available on the SPOR website under OMS: Documents.

 

Choose user-management approach

Sponsors who are new to CTIS should choose between two user-management approaches: organisation-centric or trial-centric.

The organisation-centric approach is designed for sponsors who run clinical trials on a regular basis. It enables the organisation to appoint one or more high-level administrator users to maintain oversight of the roles and access levels of all [CTIS] users within their organisation. In order to follow this approach, your organisation needs to register a high-level administrator user via the EMA Account Management portal.

The trial-centric approach is designed for sponsors who only run clinical trials on an ad-hoc basis. It is the default user-management approach is [CTIS], and is applied automatically when the organisation does not have a registered high-level administrator. Following this approach, user roles and access levels are defined at trial level by the user who creates the initial application.

For more information, see our materials available online:

 

Register your investigational medicinal products

For newly developed medicines that have not been studied in clinical trials before or authorised in the EU, sponsors need to submit medicine-related information into EMA’s Extended EudraVigilance medicinal product dictionary (XEVMPD).

Guidance on how to register investigational products on EMA’s website

Clinical trials

The information provided for a clinical trial can be submitted in one or more languages. Data and documents can be provided in all the official languages of the European Union (EU). Certain countries in the EU or the Economic European Area (EEA) may require that data is provided in a commonly understood language in the medical field, such as English, or in national language, as provided for in Article 26 of the Clinical Trial Regulation.

A key goal of the Clinical Trials Regulation is transparency for clinical trials data.

All information submitted to CTIS will be made public, unless it is found necessary not to publish it to protect:

  • Personal data
  • Commercially confidential information, in particular the marketing-authorisation status of a medicine, unless there is an overriding public interest
  • Confidential communication between EU/EEA regulators during the assessment
  • Supervision of clinical trials by EU/EEA regulators

Find out more about what information is available

Please consult Eudralex volume 10 – clinical trials guidelines, which includes the questions and answers document on the Clinical Trials Regulation, for more information and guidance related to the Clinical Trials Regulation.

Please contact the European Union Member State(s) or the European Economic Area country concerned for your clinical trial application for general guidance on clinical trial assessment processes/decision criteria.

To find the regulatory authority for medicines for human use (also known as national competent authority, or NCA) of a European Union Member State or a European Economic Area, we refer you to the overview on the European Medicines Agency’s (EMA) website.

View national competent authorities

Guidance

You can find relevant links to training, guidance and reference material on our training page.

Go to the training page

In general, good internet connectivity, some system requirements and some other recommendations which we have listed for you:

Technical requirements for optimal use of CTIS

Technical support

We recommend you consult our training and guidance to troubleshoot issues with the Clinical Trials Information System (CTIS). If answers cannot be found in these materials, users can make use of the User support service.

Our online modular training programme includes tailored questions and answers (FAQs). We also provide support and reference material to help you work with CTIS.

Transparency

Please consult the Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) version 1.1 together with its annexes (Annex I and Annex II). The guidance aims to assist sponsors and authorities in fulfilling the transparency obligations set out in the Clinical Trials Regulation. Annex I provides an overview of the expected personal data contained in referenced documents/fields and Annex II is a template for Good Clinical Practice (GCP) inspections carried out in category 1 trials where the publication of clinical trial information is delayed by a deferral.

Please also refer to the associated ACT EU_Q&A on the protection of Commercially Confidential Information and Personal Data while using CTIS, which included recommendations from the member states and product owners on frequently asked questions.

More information on the protection of publication of commercially confidential information and personal data is provided in the Appendix on Disclosure Rules, to the “Functional specifications for the EU portal and EU database to be audited – EMA/42176/2014”.

The appendix continues to apply until the revised CTIS transparency rules come into effect in 2024, following changes implemented in CTIS. Users will be notified ahead of time.

Please consult the Joint Controllership Arrangement with regards to CTIS and the related Q&A document for more information

Please consult the section Additional reference materials for CTIS users on the Clinical Trials Information System: training and support | European Medicines Agency (europa.eu), where structured data forms are published for applications, modifications, notifications, requests for information and annual safety reports. These lists provide a complete overview of data fields and documents per topic and indicate whether these are subject to publication and if publication is deferable.

Transitioning trials

Clinical trials (CTs) authorised under the Clinical Trials Directive (CTD) that are expected to continue beyond 30 January 2025 need to be transitioned to the Clinical Trials Regulation (CTR).

Details of the requirements for transitioning CTs are provided in the European Commission's Guidance for the transition of clinical trials.

The transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation (CTR) is open to sponsors from the day of the entry into application of the CTR, on 31 January 2022, until the end of the 3-year transitional period, on 30 January 2025, without the need to discontinue a clinical trial or put a trial on hold.

Sponsors should, however, take into account the time necessary for completion of the Member State procedure, which can take up to 3 months. Therefore, sponsors are strongly advised to submit the applications well in advance of the end of the transition period on 30 January 2025.

When possible, Members States have agreed on an expedited procedure for transitioning trials to the CTR. For further information please consult the CTCG Best Practice Guide.

Sponsors transitioning trials from the Clinical Trials Directive to the Clinical Trials Regulation and CTIS can consult:

  • CTIS: how to get started and how to transition a trial, a useful collection of training and reference documents for new CTIS users.
  • The Guidance for the transition of clinical trials published by the European Commission.
  • The best practice guide and accompanying annex for multinational sponsors of transitional trials adopted by the Clinical Trials Coordination Group (CTCG). The guide aims to support sponsors transitioning multinational trials with protocols, IMPD or Investigator’s Brochure that are not harmonised across Member States. The annex provides a template with information that should be provided in the cover letter of applications for transitioning a Clinical Trial authorised under the Directive to the Clinical Trial Regulation.
  • Chapter 5 of the CTIS Sponsor Handbook which includes an overview of the transition period, general considerations for transitioning trials, the assessment timelines, and information on creating and managing trials transitioned to CTIS.
  • Module 23 of the CTIS online training programme which includes instructions on how to submit a transitional trial, including submitting notifications and clinical trial results. An overview of the content is also available in the Quick Guide for Sponsors.
  • The video recording and presentation of the CTIS Bitesize talk from 21 June 2023 on how to submit a transitional trial in CTIS, available on the event page.
  • The video recording and presentation of the CTIS Bitesize talk from 23 June 2022 on transitional trials, available on the event page.
  • The video recording of the CTIS webinar on 4 July 2023 on the Second year of transition, available on the event page. The first session presented Member States' and Sponsors' experience and perspective on transitional trials, followed by a Q&A session.

In case of technical issues encountered during the submission of a transitional trial application, sponsors should raise a ticket on ServiceNow.