EMA - CTIS Newsflash, 3rd December 2024

5th December 2024

EMA - CTIS Newsflash, 3rd December 2024

• Winter Clock Stop Reminder: All timers for clinical trial application evaluations will pause from 22 December 2024 to 8 January 2025, potentially affecting application timelines. More information is available in the CTIS evaluation timelines document.
• Transition to CTR: Sponsors must transition ongoing trials from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR) by 30 January 2025 and should submit trials for transition as soon as possible to account for the time necessary for completion of the Member State(s) evaluation procedure.

• CTIS User Tips: CTIS will not undergo regular maintenance on Thursdays from 13 to 31 December 2024, allowing uninterrupted access during those hours.  Alerts for submission due dates, e.g. Start of Recruitment, will still be generated and can be ignored if the relevant submissions have already been made.  Users are encouraged to consult the updated lists of known issues and useful tips on the CTIS website before raising tickets with the CTIS User Support Service.

• ICH E6 R3 Workshop: A workshop on ICH E6 R3 will be held on 19-20 February 2025, focusing on major guideline changes and stakeholder implementation; registration is open until 10 December 2024.
• CTIS Training Environment Update: The CTIS Training Environment will be unavailable on 18 December 2024 for a system update, the update will also delete all data recorded until that date. The training environment is a simulation of CTIS used in production and allows users to get familiar with system functionalities.
• System Improvements: Recent updates include changes to trial authorizations and extensions, submission process improvements, and enhancements for Member State evaluations. More information on the latest system improvements is available in the published release notes

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