All clinical trials requiring notification to resp. authorisation by CA
Last patient - last visit at involved trial sites
Notification of early and regular trial termination must be made by using the EudraCT form “Declaration of the End of Trial” available on the European Commission website EudraLex - Volume 10 Clinical trials guidelines – Chapter I: Application and Application Form.
The forms may be filled in electronically on the EMA website, but Fimea requires submission of signed paper printouts.
Section 11 of Regulation 2/2012
In the event that a multinational trial ends in Finland earlier than at the other trial sites, a separate notification is required.
For trial interruptions and re-commencement of the trial, the EudraCT form “Substantial Amendment Notification Form” must be used.