CTIS - New Version of the Sponsor Handbook

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

The go-live date for the CTIS is 31 January 2022. The System will then become the single entry point for clinical trial application submission, authorization and supervision in the EU. In order to help sponsors prepare for using the CTIS, the EMA has recently published a Sponsor Handbook. It covers priority topics identified with the help of clinical trial sponsors, with references and links to further supporting materials (e.g. List of Acronyms / Glossary). The EMA will be updating this CTIS Sponsor Handbook with further priority topics as needed and a revised version has now been published.

Clinical Trials Information System (CTIS) - Sponsor Handbook (v. 2.00)

The Handbook is a compilation of key guidance, technical information, recommendations and references for getting ready for use of the CTIS. The following sections have been revised:

• Editorial changes across the document
• Organization Management Service (OMS) registration process (section 3.2.1) updated
• User personas and organization models (section 4.5) updated with new links
• Product management in CTIS (section 5) updated
• Transition from Directive to Regulation (section 6) updated
• Data fields and documents specifications (sections 7.1.3) new
• SUSARs reporting (section 8.1) updated
• Training environment for user training and organization preparedness (section 10.4) new

More information can be found in the Clinical Trial Information System (CTIS) - Sponsor Handbook on the EMA website.