ECAmendment object
Ethical review mandatory for
Any substantial amendments to the study protocol
Responsible for notification of SA
Sponsor
Investigator
Timeline Ethical review of SA (max nr days)
35
Guidance on submission of SA
Related information is available on the NBC website in section Clinical Trials » Amendments to Clinical Trial Protocols
Additional Information
NB! Substantial alteration in the handling of personal information may be subject for consideration by the Data Protection Authority.