Clinical Trials Information System (CTIS) bitesize talk: Notifications - Part 2
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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 notifications not related to the trial and recruitment period, e.g. unexpected event notification; urgent safety measure; serious breach etc. Sponsors will also have opportunity to ask questions on this CTIS topic 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 05 (Manage a clinical trial through CTIS) of the online modular training programme, as well as the CTIS structured data forms on Notifications.
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 participants certificates of attendance for this event.