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)
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.