ECEndOfTrial object

End of trial Declaration mandatory

Yes

Responsible for End of trial Declaration

Sponsor
Legal representative domiciled in the EU/EEA

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

"Meldungsformular" (available in German only on the website of the Forum Österreichischer Ethikkommissionen (http://www.ethikkommissionen.at) in section: Formulare, Leitlinien, Informationen, Gesetze, etc. > Meldungen)

National legal framework in place

Yes

Applicable national legal framework/ Reference

Art 32 (1) 5 AMG

Additional Information

All involved ECs (lead and local) have to be notified.

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