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Home / Templates
  • Templates REK KULMU

Templates

Maler for deg som skal søke REK

Skal du søke REK finner du lenker til maler for informasjonsskriv og samtykke under “Informasjon og samtykke” i menyen til venstre.

 

Templates for those applying to REK KULMU

For applications involving clinical trials of medicines and medical devices, go to “Templates REK KULMU” in the menu on the left.

 

Important Information:

Downloading templates does not work in all browsers (e.g., Firefox). If you experience issues, please switch to another browser such as Chrome or Edge.Nedlasting av maler fungerer ikke i alle nettlesere (f.eks. Firefox). Hvis du opplever problemer, vennligst bytt til en annen nettleser som Chrome eller Edge.

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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