CAEndOfTrial object
End of trial declaration mandatory for
All clinical investigations requiring authorisation by CA
Responsible for End of trial declaration
Sponsor
Legal representative domiciled in the respective country
Regular Termination - Declaration timespan (max nr days)
90
Early/premature Termination - Declaration timespan (max nr days)
15
Additional Information
Premature interruption of a Cat A trial for safety reasons must be reported to the EC within 7 days.
A fundamental definition for the end of the trial should be explicitly mentioned in the trial protocol. It is usually the date of the final visit by the final trial participant: LPLV (last patient, last visit).