Protocol amendments
USN
In case of protocol amendments, we will notify Sikt, TRIALS, and funder (The Norwegian Research Council) first, then the PI will notify the centers USN and HIØ, and a copy of the revised protocol will be sent to the PI to add to the Investigator Site File. We will also update the protocol in the Clinical Trial registry. Any deviations from the protocol will be fully documented using a breach report form.