December 2022: CTIS Newsflash

European Medicines Agency communicated the latest CTIS Newsflash via CTIS.communications on December 22, 2022:

A CTIS release went live on December 12, 2022, implementing the below functional improvements:

  • Resolving the issues with reporting member state (RMS)/concerned member state (MSC) raising RFIs on due dates of tasks and the extension of response due dates for sponsors
  • Allowing trial sites which cannot be registered in OMS to be recorded directly into CTIS
  • Enhancing the lock mechanism feature allowing multiple users to work on a clinical trial application
  • Ensuring visibility of documents “Agreement from another Sponsor” and “PIP Opinion” in the MS workspace following upload by Sponsor
  • Improving the MS API to display conditions provided in Part II conclusion

The next CTIS release is planned to go live on December 22, 2022, and will include several improvements resolving the issues with the task ‘Submit RFI response’ in the timetable, change of application in Part II RFI in the context of multinational clinical trial, visibility of responses to RFIs, deleting MSC in an ongoing CT.

Users are informed regarding the winter clock stop that will be in place for all CTAs that are under evaluation in CTIS. All timers within the evaluation of each CTA will stop on 22 December 2022 at 23:59:59 CET and will resume on 8 January 2023 at 00:00:01 CET. The due dates for any tasks will automatically fall on dates after this winter clock stop.