EMA offers a virtual training programme, organised by DIA, to support sponsor user preparedness for the new Clinical Trials Information System and the new way of submitting a clinical trial application and managing the life cycle of a clinical trial in the European Union (EU) and European Economic Area (EEA).

A hands-on approach is taken to explaining and demonstrating the functionalities of the system, such as user management, how to submit an initial application as well as modifications, both substantial and non-substantial. Also, how to manage the life cycle of a Clinical Trial, how to apply Deferral rules and respond to a Request for Information (RFI) will be addressed.

A blended learning approach is being used, offering components on-demand, self-paced and live virtual.

This training programme is open to sponsor users of the new CTIS: commercial and non-commercial sponsors as well as Contract Research Organisations (CROs).

Section I - These topics are offered on demand in a format of a recording which preferably should be watched before joining the live course:

Section II - These topics are offered in a live virtual course: