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Dear RA community:
As you know as of January 31st, 2023 all new trials will be required to be submitted under the new EU-CTR, and by 2025 all current trials must also be transitioned over to the EU-CTR from the EU-CTD.
My question, is that we also know if you choose to add
a new country post-January 31st a sponsor will be
required to transition the trial over to the CTR automatically, irrespective if their trial was ongoing under the old CTD. I am trying to determine if there would be any trial black out or pause period, during when an active clinical trial is being transitioned the new CTR process. I am unable to find any clarity on this specific point from public resources.
Your help would be greatly appreciated!