European Medicines Agency published the tenth Clinical Trials Information System (CTIS) newsflash over the What’s New Section on March 11, 2022:
This newsletter reports the key metrics for the period March 28, 2022, to April 03, 2022, including the total number of logins to CTIS, number of draft applications in CTIS, number of submitted applications in CTIS, and number of authorized applications in CTIS.
It informs about the first clinical trial that got authorized through CTIS. This trial is a transitional trial that was previously approved by ClinicalTrials.gov and is registered on EudraCT. Details of the trial are visible on the public database of CTIS. It provides more information about the CTIS public website and informs that once the trial has been complete sponsors must upload a summary of results in lay language.
Moreover, the newsletter reminds users that the due dates are calculated as per the timetable that harmonizes with the timeline of clinical trial assessment. It also provides the links wherein it explains how the timetable is calculated for both sponsor workspace and authority workspace.