European Medicines Agency published the eleventh Clinical Trials Information System (CTIS) newsflash over the What’s New Section on April 25, 2022:
This newsletter reports the key metrics for the period April 11, 2022, to April 17, 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, that from May 2022 the weekly publication of CTIS newsflash metrics report will be replaced by monthly publications. It also informs about the second clinical trial that got authorized through CTIS. This is the first clinical trial to be initiated through CTIS. The Member State concerned for this trial is Denmark. Details of the trial are visible on the public database of CTIS.
It explains in brief about the CTIS functionality that allows sponsors to upload versions of the required documents as ‘for publication’ and ‘not for publication’ in order to protect personal data and commercially confidential information (CCI). It informs that a draft document ‘Protection of personal data and Commercially Confidential Information in CTIS – open consultation‘ has also been published by EMA providing transparency guidelines to sponsors. It provides a link containing the details on how to provide feedback for the draft document. The last date for providing feedback is September 08, 2022.
It reminds that the third CTIS: bitesize talk will be held on April 28, 2022. It also informs that the topic for the bitesize talk has been changed to request for information (RFIs) from which sponsors can gain guidance on how to response to RFIs received from Member States during evaluation of clinical trial application.