ECAmendment object

Ethical review mandatory for

Any substantial amendments to the study protocol
Any substantial amendments (concerning investigator, trial site, informed consent)
Any substantial amendments to the study protocol, the informed consent or strategy for trial advertisement

Responsible for notification of SA

Sponsor

Applicable national legal framework/ Reference

Art 4, Deliberação n.º 514/2010, de 3 de Março (pt)
Art 18 Law 21/2014 (pt).

Additional Information

Substantial amendments to the study plan shall be simultaneously notified to the competent EC and the national CA

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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