European Medicines Agency published the fourth Clinical Trials Information System (CTIS) newsflash over the What’s New Section on March 01, 2022:
This newsletter reports the key metrics for the period February 14, 2022, to February 20, 2022, including the total number of logins to CTIS, number of draft applications in CTIS, and number of submitted applications in CTIS. The spotlight of this newsletter updates about the first clinical trial application being submitted on CTIS by a large pharmaceutical company. It informs that CTIS provides workload management tools such as the ‘Notices and alerts’ tab, ‘RFI’ tab, and ‘Tasks’ tab that helps sponsors and regulatory authorities to keep a track of their clinical trials application and tasks on CTIS.
It also provides information for users trying to get help on any CTIS issue using the EMA Service desk. It suggests users to provide a clear and detailed description of the issue and screenshots of relevant sections on CTIS wherever possible. It also explains the functionality of the below three options available in the service desk:
- Ask a question: to be used when a user needs to discuss or clarify any general subject.
- Request a service: to be used when a user needs a standard service e.g. password reset (if the standard ‘Forgot password’ process from the CTIS workspace login page does not help the user.)
- Report an issue: to be used when a user is unable to complete a task with CTIS due to a system issue.
It also reminds of the sponsor end-user training programs organized by EMA to guide users on submission of clinical trial applications and to manage clinical trials throughout their lifecycle on CTIS. The planned dates for the upcoming course are provided in the newsletter from March to June 2022.