CAEndOfTrial object
End of trial declaration mandatory for
All clinical trials requiring authorisation by CA
Responsible for End of trial declaration
Sponsor
Regular Termination - Declaration timespan (max nr days)
Not specified
Early/premature Termination - Declaration timespan (max nr days)
Not specified
Additional Information
Any trial interruptions for reasons of safety must be reported with an explanation as well as the restart of interrupted investigation with a justification.
Premature termination must be notified to the CA with a justification.
