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Home / REK KULMU / Clinical Trials Regulation (CTR) / General requirements and recommendations for a CTR application
  • REK KULMU Comittees
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  • 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 of clinical investigations (MDR)
    • Combination studies
    • Modifications to clinical investigations
  • Performance studies (IVDR)
    • Application for ethical assessment of performance studies under the IVDR
    • Combination trials
    • 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

General requirements and recommendations for a CTR application

Documents that are submitted to CTIS must be named according to these rules.
Documents that are part of an application in CTIS will, with a few exceptions, be made publicly available. It is the applicant’s responsibility to ensure that publicly available documents that are uploaded to CTIS do not contain sensitive information, such as signature, social security number and private address, so that submitted material and information is in accordance with the GDPR and other relevant privacy legislations. See CTIS Training Program modules 2 and 10 for further information.
Part I application

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)
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Current messages

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  • 14. Aug 2026

Update

Approved REK KULMU applications are not displayed in NVA (the Norwegian Research Information Repository)

Applications to REK KULMU submitted after 1 July 2026 will not be visible in NVA. This is because NVA...

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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...

Read more

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
    • Introduction to REK KULMU
    • Project registry
    • Postjournal
  • Application form
    • Prosjektsøknad
    • Generell biobank
    • Dispensasjon fra taushetsplikt annen forskning
    • CTIS
  • Templates REK KULMU
  • EN
  • NO
  • About REK / REK KULMU
    • About REK
    • Introduction to REK KULMU
    • Project registry
    • 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 of clinical investigations (MDR)
    • Combination studies
    • Modifications to clinical investigations
  • Performance studies (IVDR)
    • Application for ethical assessment of performance studies under the IVDR
    • Combination trials
    • 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