ECAmendment object

Ethical review mandatory for

Any substantial amendments

Responsible for notification of SA

Sponsor
Legal representative domiciled in the EU/EEA

Standard notification form available

Yes

Standard notification 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)

Timeline Ethical review of SA (max nr days)

35

National legal framework in place

Yes

Applicable national legal framework/ Reference

Art 37a AMG

Additional Information

All concerned 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
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