- Tuesday, 10 May 2022, 09:00 (CEST) - 13:30 (CEST)
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
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
- 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: email@example.com.
Programme - Clinical Trials Information System (CTIS) sponsor end user training programme - 2022
Interested sponsors can register for the 10 - 13 May 2022 sponsor user training course.