Procedures for Project Reports

Published 3.2.2020 
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  • Annual or extraordinary reports will only be required for cases where REC deems this necessary.

  • Ongoing reports shall not be sent to REC for clinical trials of medicines unless this is a condition of the Committee's approval.

  • The following documents should not be sent to REC as a matter of routine, but only to Statens legemiddelverk (SLV):
    • Reports on side effects and SUSARs (quarterly, half-yearly and annually).
    • Annual report to the Norwegian Medicines Agency.
    • Updates to the Investigational Medicinal Products Dossier (IMPD).
    • Updates to the Investigator Brochure (IB).
    • Dear Investigator Letter (DIL).
    • 90 day report following the conclusion of a clinical trial.
    • Final report to the Norwegian Medicines Agency.

  • If the documents mentioned in the section above deal with matters of significant importance with regard to the approval that has been granted, an application for a project amendment must be submitted or a new project application created. This applies particularly to matters of importance to the project's soundness and research participants' safety, welfare and integrity in general.

  • All projects must submit a final report to REC using the Reports form which you find at The final report should also be sent if the project is not completed as planned (section 12 of the Health Research Act).