ECAmendment object

Ethical review mandatory for

Significant changes to the project's purpose, methodology, duration or organization

Responsible for notification of SA

Sponsor

Standard notification form available

Yes

Standard notification form

The electronic Project Amendment form (Prosjektendring) is used when the Chief Investigator is to apply for continued approval for the project under terms. 

The form is available via the REK Portal (only available in Norwegian).

Timeline Ethical review of SA (max nr days)

35

Guidance on submission of SA

Detailed information is available on REK website in section Rules and Procedures >Procedures for Project Amendments

Applicable national legal framework/ Reference

Section 5(1) Regulation 2009

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