Clinical Trials Information System (CTIS) Sponsor User Training Program - January 2022

On 14 January 2022 the EMA announced the CTIS sponsor user training program.

EMA has developed this training program to support sponsor user preparedness with regard to the new way of submitting Clinical Trial Applications (CTA) in the EEA via the new Clinical Trial Information System.

A hands-on approach is taken on 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.

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