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

First published:
English (EN) (141.36 KB - PDF)View

Registration

 Interested sponsors can register for the 10 - 13 May 2022 sponsor user training course. 

Related documents

Clinical Trial Information System (CTIS) - Sponsor handbook

First published: Last updated: Reference Number: EMA/923413/2022 v. 3.03
English (EN) (1.55 MB - PDF)View

Contact point

basel@diaglobal.org

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