10/11 April 2024
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.
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.
More information can be found in the Clinical Trial Information System (CTIS) - Sponsor Handbook on the EMA website.