Clinical Trials Information System (CTIS) bitesize talk: Deferral rules and Public website

CTIS is the business tool of the EU Clinical Trials Regulation (Regulation (EU) No 536/2014) and it acts as a single entry point for clinical trial authorisation and supervision in the European Economic Area.

This bitesize talk on CTIS provides an opportunity for sponsors to learn about the deferral mechanism and how it affects publication of clinical trial data and documents. Sponsors will also have opportunity to ask questions on these CTIS topics during the event.

To be better prepared for this event, sponsors are encouraged to consult the CTIS training and support materials, focusing on the e-learning course of Module 10 (Create, submit and withdraw a clinical trial) of the online modular training programme, as well as the CTIS Structured data forms.

The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. EMA cannot provide attendees certificates of attendance for this event.