CTIS for sponsors

The sponsor workspace in the Clinical Trials Information System (CTIS) assists clinical trial sponsors and other organisations involved in running clinical trials in preparing and compiling clinical trial applications and dossiers to submit for assessment by Member States in the European Union (EU) and European Economic Area (EEA).

The revised CTIS transparency rules became applicable on 18 June 2024, with the launch of a new version of the CTIS website. Support materials and more information are available under Transparency: Questions and Answers.

Target CTIS sponsor workspace users

Clinical trial sponsors
Marketing authorisation applicants and holders
Other organisations involved in running clinical trials

Functionalities

Manage registered users and user roles
Compile clinical trial applications for new and updated or ongoing trials
Cross-reference to product documents in other clinical trials
Submit clinical trial applications and updates for assessment by Member States
Receive alerts and notifications for ongoing trials
Respond to requests for information and view deadlines
Search and access clinical trials
Issue notifications related to key milestones in the trial lifecycle (e.g. start of recruitment, end of recruitment)
Record clinical trial results

Getting started

Log in

Log in to the sponsor workspace using your EMA account. If you have access to any EMA-hosted websites or online applications requiring registration, you already have an EMA account and you should use the same credentials.

How to register

If you do not have an EMA account, you need to create an EMA account first. See EMA's training materials for more information on how to obtain user roles.

New to CTIS? You need to choose a user management approach and may need to register your organisation. You may also need to register your investigational medicine. Find out more