European Medicines Agency published the eighth Clinical Trials Information System (CTIS) newsflash over the What’s New Section on March 28, 2022:
This newsletter reports the key metrics for the period March 14, 2022, to March 20, 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 collaboration of Member States in assessing part I of the clinical trial application with the help of collaboration tools provided by CTIS to provide a harmonized single decision for this part.
It informs that sponsors can log in to the CTIS sponsor workspace by clicking on ‘Log in’ in the top right corner of the home page. Users must register for an EMA account via EMA Account Management in order to log in to CTIS.
It also informs that the first CTIS walk-in clinic was held on March 28, 2022, which provided an opportunity for sponsors to ask questions and receive practical advice from CTIS experts. The next upcoming event is CTIS bitesize talks that will be held on April 28, 2022. It mentions that questions related to the interpretation of Clinical Trials Regulation and/or processes are out of scope for both events.