ECEndOfTrial object

End of trial Declaration mandatory


Responsible for End of trial Declaration


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


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.