EMA Clinical Trials Information System - Sponsor user training programme
European Medicines Agency (EMA) has developed this training programme to support sponsor user preparedness with regard to the new way of submitting Clinical Trial Applications (CTA) in the EEA via the new Clinical Trial Information System (CTIS).
A hands-on approach is taken on 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.
Furthermore, search and download options will be demonstrated and how CTIS interacts with other EMA systems such as the XEVMPD, EMA account management and OMS. The training programme also includes information on how to submit Annual Safety Reports (ASRs) as well as Clinical Study Reports (CSRs).
A blended learning approach is being used, offering components on-demand, selfpaced and live virtual.
Participants receive access to the CTIS training environment and will practice basic functionalities during the training course.
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 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