published by 28 July 2021
EMA/299895/2021 – v. 1.00
Clinical Trials Information System (CTIS) programme
A compilation of key guidance, technical information, recommendations and references for getting ready for use of CTIS
The aim of the EMA CTIS Sponsor Handbook (“Handbook”) is to provide clinical trial sponsors representing pharmaceutical industry, SME, academia, research organisations and other clinical trial sponsor organisations with the information they need for getting ready for use of the Clinical Trial Information System (CTIS) when the Clinical Trial Regulation (CTR: Regulation (EU) No 536/2014) comes into application. The Regulation harmonises the assessment and supervision processes for
clinical trials throughout the EU, via CTIS. CTIS will contain the centralised EU portal and database for clinical trials foreseen by the Regulation.
The Handbook addresses key questions on CTIS and provides a compilation and references to key guidance, technical information, recommendations, training materials and supportive documentation to facilitate planning.
It has been developed by the European Medicines Agency (EMA) in collaboration with some representatives of industry stakeholders.
The Handbook will be revised as more information becomes available or system functionalities are updated. It is best used in conjunction with the many references to which it points, including e.g. Volume 10 of the publication “The rules governing medicinal products in the European Union” that contains guidance documents applying to clinical trials (EudraLex – Volume 10 – Clinical trials guidelines).