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

Trial completion in the respective country (multinational trials)

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

15

Standard Declaration form

1) Standard form to be used: European Declaration of the End of Trial Form
(2) Via DKMAnet

Guidance on End of trial declaration

Further details on end of trial declaration obligations are provided on the CA website in section 13 of the 'Guideline for applications for authorisation of clinical trials of medicinal products in humans'

Applicable national legal framework/ Reference

Art 89 of Danish Medicines Act

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