Clinical Trials Information System (CTIS) Sponsor End User Training Program

Clinical Trials Information System (CTIS) Sponsor End User Training Program – March 2022

On 18 January 2022 the EMA announced the CTIS sponsor end user training program being held from 1 March to 4 March 2022, for the new way of submitting, managing and reporting a clinical trial via the CTIS.

EMA has developed this training program to support sponsor user preparedness for the new Clinical Trials Information System and the new method for submitting a clinical trial application and managing the life cycle of a clinical trial in the European Union (EU) and the European Economic Area (EEA).

On-demand components, which must be completed before accessing the live offering, include Introduction to Clinical Trials Regulation (CTR), transparency, data protection and CTIS Sponsor User Personas.

Key topics covered during the live training will include:

Overview of CTIS components and system functionalities
Management of users and tools for workload planning and management
How to create, submit, update and withdraw an application
How to manage a clinical trial through CTIS and submit Clinical Study Reports (CSRs)

A blended learning approach will be used, offering on-demand components as well as live virtual instructor-led offerings.

For users who plan to train others in their organization, a separate module on training design and delivery can be added.