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).
Target CTIS sponsor workspace users
- Clinical trial sponsors
- Marketing authorisation applicants and holders
- Other organisations involved in running clinical trials
- 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
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.
Training and supporting materials are available for sponsors on how to use the Clinical Trials Information System sponsor secure workspace.
Find questions and answers on how to use CTIS.
If you cannot find an answer to your question in the guidance and Q&As, please contact the User support service.
See when this website and CTIS will be unavailable due to maintenance and upgrades, as well as an overview of system releases.
EMA news and events
Find EMA news and events related to clinical trials in the EU and the EEA.