Clinical Trials Information System: training and support

Training and supporting materials are available from the European Medicines Agency (EMA) to help users of the Clinical Trials Information System (CTIS) comply with their legal obligations. 

For information on CTIS, the Clinical Trials Regulation, and EMA's online training modules for CTIS users, see: 

• Clinical Trials Regulation
• Clinical Trials Information System (CTIS): online training modules

The CTIS sponsor handbook covers priority topics identified with the help of clinical trial sponsors, with references and links to further supporting materials.

It is aimed at pharmaceutical companies, contract research organisations (CROs), small and medium-sized enterprises (SMEs), academic sponsors and other organisations working on clinical trials.

EMA regularly updates the handbook. 

This document is for CTIS sponsor and authority users and includes:

• an overview of timelines and deadlines for tasks and actions across the Clinical Trial Application process
• an explanation of the dynamic character of the workflow - earlier completion of a task (before its deadline) might cause recalculation of the deadline of subsequent or relevant tasks, changing effectively their initially projected deadlines

Reference materials are available below to help users work with CTIS. 

EMA offers live training sessions to provide additional learning opportunities, including bitesize talks, walk-in clinics and webinars.  

Recordings and supporting materials become available after each event. 

You can look up both past and upcoming events below: 

EMA is working closely with master trainers, a core group of users who will train and support other users in their organisations in preparing to work with CTIS.

Master trainers from the national competent authorities and ethics committees of each EU Member State have been working with EMA since October 2020.

A programme for Master trainers for sponsors in pharmaceutical companies, including contract research organisations (CROs) took place in 2021. 

Guidance is available on training techniques and materials to support master trainers, or anyone responsible for rolling out the CTIS training programme.

Guidance is available for CTIS users on the protection of personal data and commercially confidential information while using CTIS.   

This aims to assist sponsors and authorities in fulfilling the transparency obligations set out in the Clinical Trials Regulation.

A public consultation on this guidance concluded in 2022.

The European Commission, EMA and the Heads of Medicines Agency (HMA) prepared a questions and answers document on data protection.

For more information on processing and protection of personal data, see: 

• Clinical Trials Information System: Processing of personal data