European Medicines Agency published the seventh Clinical Trials Information System (CTIS) newsflash over the What’s New Section on March 18, 2022:
This newsletter reports the key metrics for the period March 07, 2022, to March 13, 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 request for information (RFI) functionality that helps the Member States to request information from sponsors to assist in the assessment of clinical trial applications.
It discusses the CTIS Technical requirements for optimal use document that was uploaded by EMA to provide information on technical aspects that users can consider while working on CTIS.
It mentions the CTIS walk-in clinics that will be conducted twice a month that will provide an opportunity for sponsors to ask questions to CTIS experts related to any functionality of CTIS. The first walk-in clinic will be held on March 28, 2022. In addition to walk-in clinics, bite-size talks will be held once a month that will be focused on a specific functionality including a live demonstration by the CTIS experts followed by a Q&A session. The next bitesize talk will be held on March 23, 2022, which will discuss the initial clinical trial application.