EMA - CTIS Handbook on the website

10th August 2021

The EMA Clinical Trial Information System (CTIS) Sponsor Handbook is now available on the EMA website.

The handbook provides clinical trial sponsors with simple guidance on topics related to sponsor preparedness and use of CTIS, including links to reference material.

The handbook, developed in collaboration with sponsor user representatives, can be used by pharmaceutical companies, contract research organisations, small and medium-sized enterprises, academic sponsors and other organisations working on clinical trials.

A set of prioritised topics has been defined for the first version but additional topics will be added to next versions.

The European Commission has confirmed that the entry into application of the Clinical Trial Regulation and hence the go-live date for the CTIS will be on 31 January 2022. 

EMA has created an extensive training programme to help clinical trial sponsors prepare for using CTIS. Modules are available for use on the CTIS online modular training programme webpage on the EMA website.
 

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