ECEndOfTrial object

End of trial Declaration mandatory

Yes

Responsible for End of trial Declaration

Sponsor

Regular Termination - Declaration timespan (max nr days)

90

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)

15

Reasons for early termination shall be clearly stated

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)

Applicable national legal framework/ Reference

Article R1123-59 CSP

Additional Information

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
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