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Home / REK vest

REK vest

Geographical region:
Rogaland, Vestland (Hordaland, Sogn og Fjordane)

Postal address:
University of Bergen, Faculty of Medicine, PO Box 7804, 5020 Bergen

Visiting address:
Armauer Hansens Hus, north wing, 2nd floor, Haukelandsveien 28, Bergen

E-mail: rek-vest@uib.no

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
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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