Procedures for Project Reports

Published 22.4.2014 
COLOURBOX1025378 rapport.jpg
  • 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 under the menu option Deadlines and Forms - Forms for Research Projects. The final report should also be sent if the project is not completed as planned (section 12 of the Health Research Act).