CAEndOfTrial object
End of trial declaration mandatory for
All clinical investigations requiring authorisation by CA
Responsible for End of trial declaration
Sponsor
Regular Termination - Declaration timespan (max nr days)
90
Early/premature Termination - Declaration timespan (max nr days)
15
Standard Declaration form available
Yes
Standard Declaration form
Standard form to be used “Notification of the completion of clinical investigations of medical devices” is available on the CA website in section:
Medicines & medical devices / Medical devices / Clinical investigations / Application
Guidance on End of trial declaration available
Yes
Guidance on End of trial declaration
Detailed guidance is available on the CA website in section: Medicines & medical devices / Medical devices / Legislation and Guidance / Guidance / Guidance on application
