Date

Tuesday, 10 May 2022, 09:00 (CEST) - 13:30 (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 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.

Documents

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

English (EN) (141.36 KB - PDF)View

Registration

Related documents

Contact point

How useful do you find this page?

Your rating
Please do not include any personal data, such as your name or contact details. If you want to ask a question or request information from EMA, please Send a question to the European Medicines Agency.