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)

90

Timespan counted from

Last patient last visit

Early/premature Termination - Declaration timespan (max nr days)

15

Standard Declaration form

National studies: no specific form
Multinational studies: The European “Declaration of the end of trial form”.

Guidance on End of trial declaration

Related information is provided on the NoMA website in section Statens Legemiddelverk > English > Clinical trials > Regulation.

Applicable national legal framework/ Reference

Section 8(5) of Regulation 2009 for clinical trials

Additional Information

Reporting timeline: without delay

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
Feedback