6. Getting started

The project can start when:

  • It has been approved by REK.
  • The project manager has checked that the person/entity responsible for research has been informed.
  • The research participants have signed the consent form.
  • The Norwegian Medicines Agency (Statens legemiddelverk) or the Norwegian Directorate of Health has not expressed any objections within 60 days after they have received an application from the project manager for research on medicines or research in which medical equipment is used on human subjects.
  • The project has been registered in ClinicalTrials.

In connection with the initiation of new projects, the project manager must register the project in the unit's accounting system in cooperation with the project economist for the unit.

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Version 1.0. Date: 1 January 2012