CAEndOfTrial object

End of trial declaration mandatory for

All clinical investigations requiring authorisation by CA

Responsible for End of trial declaration

Sponsor
Principal Investigator (if no sponsor related to study)

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

European Declaration of the End of Trial Form

Guidance on End of trial declaration available

Yes

Guidance on End of trial declaration

Standard declaration form to be used (Declaration of the End of Trial Form) + related information is available on the IMA website in section Home > Licences > Clinical Trials > Notification and Reports

National legal framework in place

Yes

Applicable national legal framework/ Reference

Art 17 Regulation no 433/2004

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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