Latest Information on the EMA's Clinical Trials Information System (CTIS)

The EMA has modernised the CTIS (Clinical Trial Information System): with the completely revised Sponsor Handbook (version 6.0), updated forms (Structured Data Forms) and an adapted training programme, CTIS is now even more accessible and practical for users. The integration of old training modules into a uniform documentation reduces complexity and improves the user experience. The combination of digital training formats and the available sandbox strengthens preparation for CTIS processes and efficiently supports compliance with the Clinical Trials Regulation.

Updated content

1.    New Sponsor Handbook (Version 6.0)

• Official reference document for all sponsors (pharmaceutical companies, CROs, academic institutions, etc.) when submitting and maintaining clinical trials via CTIS
• Version 6.0 integrates all training modules from previous CTIS training materials. The section on multi-factor authentication (MFA) has been specifically revised and can now be found in section 1.1 (formerly 2.1.1)

2.    CTIS Structured Data Forms

• The data sheet forms (XLSX) for initial applications, additional Member States (MSC), changes (substantial/non-substantial), RFI requests, notifications, annual reports (ASR) and results were also updated and published on 9 July 2025.

3.    Training materials & Bitesize Events

• The EMA offers a CTIS 'Bitesize Talk' format: On 9 July 2025, a special session was held to introduce the new Sponsor Handbook
• In general, Bitesize Talks cover topics such as change processes, notifications, transparency rules and other modules
• In addition, there are walk-in clinics, webinars and troubleshooting sessions on CTIS use, the recordings and materials of which are made available

4. Assistance & Support

• The CTIS sandbox environment (training environment) is available to users, who can apply for access as needed via an EMA self assessment - however, multi-factor authentication is not available in this environment
• Further assistance is available via FAQs, the CTIS support page and national contact points for structured data queries

Read the full announcement 'Clinical Trials Information System (CTIS): training and support' on the official EDQM website.