CAEndOfTrial object

End of trial declaration mandatory for

All clinical trials requiring notification to resp. authorisation by CA

Responsible for End of trial declaration

Sponsor
Investigator

Regular Termination - Declaration timespan (max nr days)

90

Timespan counted from

Last patient - last visit at involved trial sites

Early/premature Termination - Declaration timespan (max nr days)

15

Reasons for early termination shall be clearly stated

Yes

Standard Declaration form

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.

Guidance on End of trial declaration

Section 11 of Regulation 2/2012

Applicable national legal framework/ Reference

Section 11 of Regulation 2/2012

Additional Information

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.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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