European Medicines Agency published the third Clinical Trials Information System (CTIS) newsflash over the What’s New Section on February 23, 2022:
This newsletter reports the key metrics for the period January 31, 2022, to February 13, 2022, including the total number of logins to CTIS, number of draft applications in CTIS, and number of submitted applications in CTIS. It explains, in brief, the two user management approaches (organization management approach and trial-centric approach) for all kinds of clinical trial sponsors.
It informs that CTIS is based on a set of timers that provide stringent
deadlines for the various steps taken by the Member State and actions of sponsor during the clinical trial evaluation, such as responding to RFIs. More detailed information about the timers in CTIS and the rules for their calculation are provided in section 5: Timetable of the below Module 04 – Support with workload management of the e-learning course for both the workspaces:
It also informs about the first open bitesize talks that will be held on February 24, 2022. The first talk will cover the user access and role management functionality in CTIS and will be live broadcasted from the EMA event page. No registration is required for the bitesize talks.