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.

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