ECAmendment object

Ethical review mandatory for

Any substantial amendments to the study protocol

Responsible for notification of SA


Timeline Ethical review of SA (max nr days)


Guidance on submission of SA

Related information is available on the NBC website in section Clinical Trials » Amendments to Clinical Trial Protocols

Applicable national legal framework/ Reference

Art 15 Regulation no 433/2004

Additional Information

NB! Substantial alteration in the handling of personal information may be subject for consideration by the Data Protection Authority.