CAEndOfTrial object
End of trial declaration mandatory for
Multi-national trials (declaration of global end)
Responsible for End of trial declaration
Sponsor
Regular Termination - Declaration timespan (max nr days)
90
Early/premature Termination - Declaration timespan (max nr days)
15
Reasons for early termination shall be clearly stated
Yes
Standard Declaration form available
Yes
Standard Declaration form
EudraCT-form End of Trial (B7)
Additional Information
Premature termination: shall be notified this within 15 days to the reviewing committee (MREC or CCMO) and, in case of a research with a medicinal product, also to the CA (CCMO or VWS) and CA of other member states stating the reason for termination.
National trials: Regular trial termination need not be notified to the CA.