EMA Updates Clinical Trial Information System with New Sponsor Handbook and Training Tools

The European Medicines Agency (EMA) has modernised the Clinical Trial Information System (CTIS) to make it more accessible and user-friendly. Key updates include the release of the Sponsor Handbook Version 6.0, revised Structured Data Forms, and an expanded training programme.

The new Sponsor Handbook, now the central reference for all sponsors—including pharmaceutical companies, CROs, and academic institutions—consolidates previous training materials into a single document. It also features an updated section on multi-factor authentication. In addition, the Structured Data Forms (XLSX) for applications, Member State submissions, amendments, notifications, annual reports, and trial results were revised and published on 9 July 2025.

To support users, EMA continues to offer Bitesize Talks, webinars, troubleshooting sessions, and walk-in clinics, with materials available online. A sandbox training environment remains accessible for practice, while further assistance is provided via FAQs, the CTIS support page, and national contact points.

29-08-2025