ECAmendment object

Ethical review mandatory for

Any substantial amendments to the study protocol

Responsible for notification of SA

Sponsor

Timeline Ethical review of SA (max nr days)

20

Applicable national legal framework/ Reference

Art 18 Law 21/2014 (pt)

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