European Medicines Agency published the first Clinical Trials Information System (CTIS) newsflash over the What’s New Section on February 07, 2022:
This newsletter reports the key metrics for the period January 31, 2022, to February 03, 2022, including the total number of logins to CTIS, number of draft applications in CTIS, and number of submitted applications in CTIS. It mentions that in the initial days of CTIS, this news flash will give regular updates on facts and figures of CTIS usage and provide useful reference materials. The spotlight of this newsletter updates about the first clinical trial being submitted on CTIS by an academic sponsor and is ready for review by the regulatory authority.
It informs that EMA will perform regular system updates to CTIS to ensure smooth operation for users. To do so, CTIS ‘maintenance windows’ are introduced when CTIS will be intermittently unavailable for system improvements. It is advised that CTIS users avoid accessing the system at the following times:
- Each Tuesday and Thursday from 18:00 to 21:00 CET.
- The first Saturday of each month from 10:00 to 14:00 CET.
To access CTIS, users must register for a user account via EMA Account Management. Users with an account that has been inactive for more than 6 months will need to re-activate their account by clicking on ‘Forgot Password’ on the secure workspace login page (for the sponsor workspace here and for the authority workspace here ) and resetting their password.