CAEndOfTrial object
End of trial declaration mandatory for
All clinical investigations requiring authorisation by CA
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
Applicable national legal framework/ Reference
Art 54 Medical Device Act 2010 (en)/
Health Minister Order 15 Nov 2010 (related details on the final report)
Additional Information
In case of a multinational investigation, the relevant bodies of the Member States shall be notified of completing the clinical investigation.
Premature termination: The sponsor shall also notify the relevant bodies of the Member State and the European Commission if the investigation has been early terminated due to safety considerations.
