ECEndOfTrial object

End of trial Declaration mandatory

Yes

Responsible for End of trial Declaration

Sponsor
Legal representative domiciled in the EU/EEA

Regular Termination - Declaration timespan (max nr days)

90

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

15

Reasons for early termination shall be clearly stated

Yes

Standard Declaration form

Available on ANSM website in section: Activités > Médicaments et produits biologiques > Avis aux promoteurs - Formulaires

Applicable national legal framework/ Reference

R1123-59 CSP

Additional Information

In case of multinational clinical trial, the sponsor has to declare when the trial ends in France and when the trial ends in all countries.
The sending of a summary of the final report and of the results to the EC by one year after the end of the trial is not mandatory but can be appreciated.

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
Feedback