European Medicines Agency published the ninth Clinical Trials Information System (CTIS) newsflash over the What’s New Section on April 05, 2022:
This newsletter reports the key metrics for the period March 21, 2022, to March 27, 2022, including the total number of logins to CTIS, number of draft applications in CTIS, and number of submitted applications in CTIS. It informs in brief about the flexible options provided by CTIS for the submission of quality documents for the investigational medicinal product dossier (IMPD-Q). It mentions that sponsors can either submit IMPD-Q documents via CTIS admin user role or Q-IMPD preparer, or cross-reference to an already submitted clinical trial. It discusses the CTIS roles that can be assigned to corroborate the confidentiality of the commercially sensitive nature of IMPD-Q.
It reminds users to refer to documents of known issues and their workarounds uploaded on the CTIS website to understand the issues and complete the processes without any hindrance.
It mentions that the recording of the first CTIS bitesize talk is now available on the event page. It also informs about the success of the first walk-in clinic held on March 28, 2022. CTIS walk-in clinics provide an opportunity for sponsors to ask questions to CTIS experts related to any functionality of CTIS. The next walk-in clinic will be held on April 22, 2022.
The newsletter also informs about the new webpage added to the EMA website explaining the obligations for clinical trials sponsors for reporting safety information in clinical trials.