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

"Meldungsformular" (available in German only on the website of the "Forum Österreichischer Ethikkommissionen" in section: Meldungen)

Applicable national legal framework/ Reference

Art 60(2) MPG

Additional Information

The favourable opinion is sent to CA.