CAEndOfTrial object

End of trial declaration mandatory for

All clinical trials requiring authorisation by CA

Responsible for End of trial declaration

Sponsor
Manufacturer acting as sponsor

Regular Termination - Declaration timespan (max nr days)

90

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

Within two working days and no later than four calendar days

Reasons for early termination shall be clearly stated

Yes

Guidance on End of trial declaration

Related information is available on IGZ website in section: Home>English>Medical devices>Clinical research involving the use of medical devices or on CCMO website in section: Home>Investigators>Types of research>Research with a medical device

Applicable national legal framework/ Reference

Art 13(5) Medical Devices Decree (Dutch)

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
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