Clinical Trials Information System (CTIS) sponsor end user training programme - November 2022

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

On-demand components, which must be completed before accessing the live offering, include:

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

Key topics covered during the live virtual offering include:

• Overview of CTIS components and system functionalities
• Sponsor User Access Management
• Management of registered users (Role Matrix)
• Workload management. Work-planning and management tools
• Create, submit and withdraw an initial application; Update 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

This event is aimed at sponsor users of the Clinical Trials Information System.

For any questions regarding course registration please contact: basel@diaglobal.org.

•  Interested sponsors can register for the 7-10 November 2022 sponsor user training course.