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Home / REK KULMU

Committees for clinical trials of medicines and medical devices

The committees for clinical trials of pharmaceuticals and medical devices – REK KULMU – have a national mandate where the committees must conduct a research ethics assessment of applications concerning clinical trials of pharmaceuticals and medical devices.

REK illustasjon

CTR

Research ethics assessment of pharmaceutical studies

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MDR

Research ethics assessment of clinical trials of medical devices

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IVDR

Research ethics assessment of clinical trials of in vitro diagnostic medical devices

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Templates

Template for information letter

Go to templates

Important shortcuts

  • DMPs website
  • Templates REK KULMU
  • Regulatory guide for clinical trials according to the MDR (only available in Norwegian)
  • DMPs website
  • Templates REK KULMU
  • Regulatory guide for clinical trials according to the MDR (only available in Norwegian)
Illustrasjon av leger

Current messages

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  • 20. Jun 2025

Update

New layout in the REC portal

The REK portal has undergone a necessary upgrade that involves some changes in appearance and layout. Here is an...

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  • 14. Feb 2025

CTRIVDRMDR

Updated templates for informed consent forms

There are updated templates for informed consent forms for studies that are regulated by CTR, MDR or IVDR at...

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  • 24. Nov 2024

How to activate 2-step verification when logging in to REK-portalen

It is now possible for users of the REK portal to activate 2-step verification when logging in to REK-portalen....

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Get notified about changes to the website

REK

General inquiries should be directed to the REK in your geographical region.

REK KULMU

For questions regarding the ethical assessment of clinical trials under CTR, MDR, and IVDR, please contact via email: rek-kulmu@medisin.uio.no

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  • About REK / REK KULMU
    • About REK
    • About REK KULMU
    • Prosjektregister
    • Postjournal
  • Application form
    • Prosjektsøknad
    • Generell biobank
    • Dispensasjon fra taushetsplikt annen forskning
    • CTIS
  • Templates REK KULMU
  • EN
  • NO
  • About REK / REK KULMU
    • About REK
    • About REK KULMU
    • Prosjektregister
    • Postjournal
  • Application form
    • Prosjektsøknad
    • Generell biobank
    • Dispensasjon fra taushetsplikt annen forskning
    • CTIS
  • Templates REK KULMU
  • EN
  • NO
Prosjektregister

REK

  • About REC

REK KULMU

  • REK KULMU Comittees
  • Meetings
  • REK KULMU
  • Clinical Trials Regulation (CTR)
    • EU application portal CTIS
    • General requirements and recommendations for a CTR application
      • Modification application CTIS
      • Part I application
      • Part II application (national application)
        • Recruitment
        • Information to study participants and consent form
        • Suitability of the investigator
        • Suitability of the facilities
        • Proof of insurance cover or indemnification
        • Financing and other arrangements
        • Compliance with national requirements on Data Protection
        • Compliance with use of biological samples
          • Use of biological material for future research
  • Clinical investigations of medical devices (MDR)
    • Application to REK for MDR studies
    • Clinical trials of medical device that are subject to application or notification to NoMA
    • Combination trials
    • Storage period of personal data
    • Modification applications to NoMA
  • Clinical investigations of in vitro diagnostic medical devices (IVDR)
    • Application to REK for IVDR studies
    • Performance studies that are subject to application or notification to NoMA
    • Combination trials
    • Storage period of personal data
    • Modification application performance studies
  • Information forms CTR/MDR/IVDR
    • Inclusion of minors in reserach
    • Informed consent forms for broad consent
  • Templates REK KULMU
  • Answers to frequently asked questions
  • About REK / REK KULMU
    • About REK
    • About REK KULMU
    • Prosjektregister
    • Postjournal
  • Application form
    • Prosjektsøknad
    • Generell biobank
    • Dispensasjon fra taushetsplikt annen forskning
    • CTIS
  • Templates REK KULMU
  • EN
  • NO
  • About REK / REK KULMU
    • About REK
    • About REK KULMU
    • Prosjektregister
    • Postjournal
  • Application form
    • Prosjektsøknad
    • Generell biobank
    • Dispensasjon fra taushetsplikt annen forskning
    • CTIS
  • Templates REK KULMU
  • EN
  • NO
Project register

REK

  • About REC

REK KULMU

  • REK KULMU Comittees
  • Meetings
  • REK KULMU
  • Clinical Trials Regulation (CTR)
    • EU application portal CTIS
    • General requirements and recommendations for a CTR application
      • Modification application CTIS
      • Part I application
      • Part II application (national application)
        • Recruitment
        • Information to study participants and consent form
        • Suitability of the investigator
        • Suitability of the facilities
        • Proof of insurance cover or indemnification
        • Financing and other arrangements
        • Compliance with national requirements on Data Protection
        • Compliance with use of biological samples
          • Use of biological material for future research
  • Clinical investigations of medical devices (MDR)
    • Application to REK for MDR studies
    • Clinical trials of medical device that are subject to application or notification to NoMA
    • Combination trials
    • Storage period of personal data
    • Modification applications to NoMA
  • Clinical investigations of in vitro diagnostic medical devices (IVDR)
    • Application to REK for IVDR studies
    • Performance studies that are subject to application or notification to NoMA
    • Combination trials
    • Storage period of personal data
    • Modification application performance studies
  • Information forms CTR/MDR/IVDR
    • Inclusion of minors in reserach
    • Informed consent forms for broad consent
  • Templates REK KULMU
  • Answers to frequently asked questions