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Dear all,
Do you have any experience about the submission of a protocol amendment before transitioning the study to the EU CTR?
The CTR QA document provides the following:
If a clinical trial would not fully comply with the CTR, a sponsor shall request a substantial amendment under the CTD before switching to the regulatory framework of the CTR, specifying its intention to align the trial with the CTR. Only after the substantial amendment is accepted, a sponsor can follow the procedures described below to switch the clinical trial to the regulatory framework of the Regulation.
For a multinational study, would you still recommend to submit this amendment under the CTD even if the the changes are non substantial and would only be related to the format (e.g including a country specific appendix)?
Thanks for your insights