Project Amendments

Published 12.1.2012 
  • The Project Amendment form (Prosjektendring) is used when the Chief Investigator is to apply for continued approval for the project under terms.

  • An application for approval must be submitted for significant changes to the project's purpose, methodology, duration or organisation (section 11 of the Health Research Act). Changes of significance to the acceptability of the project and the safety, welfare and general integrity of participants - for example new information about risks and benefits - must also be notified.

  • An application for the approval of changes shall not be submitted for changes that apply to the following: technical study material (participant cards, diary, medical bags etc.), the number of reserach participant per centre where the total number of participants is unchanged, the Chief Investigator in another country, the Contract Research Organisation (CRO) or the pharmaceutical, chemical or biological qualities of the trial substance.

  • Further information about project changes that must be submitted to REC can be found under the menu options Rules and Prodecures - Procedures for Amendments and Reports.

  • When you are logged on to the portal you will se link to the form Prosjektendring underneath this text. The form is only available in Norwegian.

  • The form is a dynamic screen dialogue. Information is obtained from the user profile and previous applications made by the person logged on. Submitted answers guide subsequent questions in the form.