CAEndOfTrial object
End of trial declaration mandatory for
All clinical investigations requiring authorisation by CA
Responsible for End of trial declaration
Sponsor
Manufacturer acting as sponsor
Regular Termination - Declaration timespan (max nr days)
No timeline specified in national law
Early/premature Termination - Declaration timespan (max nr days)
No timeline specified in national law
Reasons for early termination shall be clearly stated
Yes
Standard Declaration form available
No
Standard Declaration form
No special form; should be announced by letter.
Additional Information
CAs of Member states of the EEA shall be also notified of the conclusion of a clinical investigation on MD.
