CTIS lecture at the Master G. Benzi – University of Pavia
CTIS serves to implement EU pharmaceutical law in the Clinical Trials Regulation (Regulation (EU) No 536/2014) and supports the flow of information between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) countries and the European Commission. The system went live with a searchable public website on January 31 2022 and is currently transitioning from the former EudraCT, ending on January 30, 2025.The lecture dealt with the following topics:
- New concepts in Clinical Trial Information System (CTIS)
- Transition from the Directive to the Regulation
- Overview of the sponsor workspace
- Management of users and organisations in CTIS
- How CTIS Clinical Trial Application process works
- Revised CTIS Transparency Rules.