CAEndOfTrial object

End of trial declaration mandatory for

All clinical trials requiring authorisation by CA

Responsible for End of trial declaration

Sponsor
Legal representative domiciled in the EU/EEA

Regular Termination - Declaration timespan (max nr days)

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

Reasons for early termination shall be clearly stated

Yes

Standard Declaration form

1) Declaration of the End of Trial Form (en) of EudraLex Volume 10 Guidelines OR
2) Formulaire FFE - Déclaration de fin de recherche biomédicale (fr).
The templates for both forms (+ final report) are available for download on ANSM website in section: Activités > Médicaments et produits biologiques > Avis aux promoteurs - Formulaires.

Guidance on End of trial declaration

"Avis aux promoteurs-Tome 1":
A comprehensive guidance for sponsors is published on the ANSM website in section: Activités > Médicaments et produits biologiques > Avis aux promoteurs - Formulaires.
It covers in detail the legal framework, the submission procedure and all other relevant requirements on amendments, safety reporting and trial termination (applicable for studies submitted after august 2006).

Applicable national legal framework/ Reference

R1123-59 CSP

Additional Information

In case of multinational clinical trials, the sponsor has to declare when the trial ends in France and when the trial ends in all countries.
The participants have the right to be informed of the outcome of a clinical trial.

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