Clinical Trials Information System (CTIS) demonstration for stakeholders

The way clinical trials are conducted in the European Union/EEA underwent a major change when the Clinical Trials Regulation (Regulation (EU) No 536/2014) came into application on 31 January 2022. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS), which contains the centralised EU portal and database for clinical trials foreseen by the Regulation.

In preparation for the go-Live of CTIS on 31 January 2022, EMA hosted a virtual CTIS demonstration aiming to showcase the status of the system and explain how to perform real-life business cases by walking the audience through the workflow of a typical clinical trial in CTIS. This was a closed event with invites sent to stakeholders who were involved in the CTIS project.

This virtual event was recorded and the videos are open to all users of CTIS, such as sponsor organisations (including pharmaceutical companies), contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations.