Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical trials have ended.

End of Trial declaration

The end of the clinical trial is defined in the protocol. The purpose of the EoT declaration is to inform regulatory authorities and ethics committees when a clinical trial had been completed or terminated in their country and/or worldwide.

EoT declaration in the European Union

In the European Union, the sponsor must submit the EoT declaration to the regulatory authorities and ethics committees of all member states when the study has been completed worldwide (in some member states, a declaration should be submitted when the study has been completed nationally as well). The EoT declaration must be submitted within 15 days in case of an early termination of a trial or within 90 days when the trial has been completed according to the protocol. Information on the end of the trial is published in the EU clinical trials register by the member states.