Clinical Trials Information System (CTIS) sponsor end user training programme - September 2024

This is a hands-on training that covers user management, clinical trial life cycle, modifications, and responding to RFIs. Featuring a blended learning approach with on-demand, self-paced, and live virtual sessions.

• Date:
  Monday, 23 September 2024 , 09:00 - 13:30 Amsterdam time (CEST)
  Tuesday, 24 September 2024 , 09:00 - 13:30 Amsterdam time (CEST)
  Wednesday, 25 September 2024 , 09:00 - 13:30 Amsterdam time (CEST)
  Thursday, 26 September 2024 , 09:00 - 13:30 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

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, 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.

Who should attend?

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

Learning objectives

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

• Introduction to Clinical Trials Regulation (CTR) (EU) No 536/2014
• Transparency
• Data protection in CTIS
• CTIS Sponsor User Personas

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

• Overview of CTIS components and system functionalities
• Sponsor User Access Management,
• Management of registered users (Role Matrix)
• Create, submit and withdraw an initial application; Update the initial application through other applications (substantial modifications, additional MSC)
• Respond to Request for Information (RFI) received during the evaluation
• Manage a Clinical Trial through CTIS
• Sponsor search, view and download a Clinical Trial and Clinical Trial Application (CTA)
• Create and submit an Annual Safety Report and respond to related RFIs
• Clinical Study Reports (CSR) submissions

Registration

Interested sponsors can register for the September 2024 sponsor user training course