Clinical Trials Information System (CTIS) sponsor end user training programme - February 2023
Table of contents
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, how to apply Deferral rules 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).
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
- 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