ECEndOfTrial object
End of trial Declaration mandatory
Yes
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)
Guidance on End of trial declaration
CCMO website in section Home>Investigators>During and after the research>End of study
Applicable national legal framework/ Reference
Section 13(l) WMO (en)
Additional Information
The date of the global end of trial shall be declared within 90 days to the reviewing committee (MREC or CCMO) and to the CA (CCMO or Ministry of Health, Welfare and Sport), using the EudraCT-form End of Trial (B7).
Submission Format:
CCMO (if reviewing committee) by post or digitally to tc@ccmo.nl
MREC/METC: variable
