Clinical Trial Information System - EMA publishes Sponsor Handbook

Recommendation

3/4 November 2021

Complaint Handling and Recall Management - Live Online

It has been officially announced: The go-live date for the Clinical Trials Information System (CTIS) is 31 January 2022. The CTIS will then become the single entry point for clinical trial application submission, authorization and supervision in the EU, and in the EEA countries Iceland, Liechtenstein and Norway. In order to help sponsors prepare for using the CTIS, the EMA has recently published a new 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). According to the agency, the handbook is aimed at pharmaceutical companies, contract research organizations (CROs), small and medium-sized enterprises (SMEs), academic sponsors and other organizations working on clinical trials.

EMA´s Sponsor Handbook

The Handbook is a compilation of key guidance, technical information, recommendations and references for getting ready for use of the CTIS. The EMA will be updating this CTIS Sponsor Handbook with further priority topics as needed.

Content overview

• What CTIS is and what it does
• CTIS Go-Live date
• Getting access
• Management of users and organizations (including key user management & user roles concepts)
• Product management (including product registration, search & selection)
• Transition from Directive to Clinical Trial Regulation (e.g. transition period)
• Data, documentation and processes (e.g. download options, document modifications, handling of requests for information)
• Safety reporting obligations (e.g. suspected unexpected serious adverse reactions, annual safety report)
• Data transparency
• Support (e.g. Helpdesk at EMA)
• Other references
• Acronyms and Glossaries

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