CAEndOfTrial object

End of trial declaration mandatory for

All clinical investigations requiring authorisation by CA

Responsible for End of trial declaration

Sponsor
Legal representative

Regular Termination - Declaration timespan (max nr days)

Timespan counted from

Last participant - last visit in the respective country
Last participant - last visit in all involved countries (multinational trials)
NB: Two declarations might be required, if the research does not come to an end simultaneously in France and in all the other countries concerned

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

Reasons for early termination shall be clearly stated

Yes

Standard Declaration form available

Yes

Standard Declaration form

"Form of declaration of end of trial" (Formulaire 10)
Available on the ANSM website in section: Activités > Dispositifs médicaux > Essais cliniques portant sur les dispositifs médicaux et dispositifs médicaux de diagnostic in vitro > Formulaires et modèles à télécharger (Forms and Downloads)

Guidance on End of trial declaration available

Yes

Guidance on End of trial declaration

'Avis au promoters/ Notice to sponsors':
Contents of the dossier and required format of the end of trial declaration is specified in section 4.3.1 of the comprehensive guidance (available on the ANSM website in section: Activités > Dispositifs médicaux > Essais cliniques portant sur les dispositifs médicaux et dispositifs médicaux de diagnostic in vitro > Avis aux promoteurs / fiches (Notice to sponsors/ guidelines)

Applicable national legal framework/ Reference

Article L 1123-11 of the CSP
Article R. 1123-59 of the CSP
End of Trial Decree: Order of 25 August 2006 relating to the contents and the methods of presentation of information relating at the end of research, the final report and the summary of the final report of a biomedical research relating to a DM or DM-DIV

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