• Norsk Bokmål
  • Guidance and support
    • Are you planning a clinical study?
    • ECRIN-ERIC: Are you a partner in a multinational trial?
    • Guidance for clinical research
    • Data collection tools
    • Manufacture of medicinal products
    • Clinical research networks
    • Monitoring
    • Early-phase units
    • The Norwegian Medicines Agency (SLV) – clinical guidance
    • Regional Committees for Medical and Health Research Ethics (REK)
    • Overview of projects and biobanks in Cristin
    • Contract Research Organisations (CRO) – companies in Norway
    • Educational video: clinical trials
  • Procedures
    • Implementation of procedures (SOPs) at each regional health authority, health trust or institution
    • Clinical Drug Trials
    • Flowchart for use of the procedures (SOP’s)
    • Clinical tests of medical devices
    • Clinical testing of other interventions
  • Courses and activities
    • GCP courses under the auspices of NorCRIN partners
    • GCP e-learning course
    • Side effect/safety reporting
    • Course providers other than NorCRIN
    • International Clinical Trials Day (ICTD)
  • News
    • News about the ongoing coronavirus pandemic
  • For industry
  • Useful info
    • Useful links
    • For patients – ask about ongoing trials
    • Patient travel
    • User, patient and support organisations
    • Status of the implementation of new regulations on medicinal products
    • Downloading logos etc.
  • About NorCRIN
    • What is NorCRIN?
    • Contact NorCRIN
    • Project organisation
    • NorCRIN Board
    • NorCRIN partners
    • Prioritisation of projects
    • User involvement
    • Support for KLINBEFORSK trials
    • Collaborative research networks
    • Collaborative research networks
    • Portfolio
  • ECRIN
Slide image

Are you planning a clinical study?

Are you involved in clinical research and need assistance and advices?
Read more here
Clinical trials of medicinal products

For clinical trials of medicinal products in humans, a comprehensive procedure has been established to ensure quality in all stages of the trial. Guiding principles are set out in “Good Clinical Practice” (ICH-GCP).

SOPs, templates, checklists, forms and logs.
Clinical tests of medical devices

For testing in connection with CE marking of medical devices involving humans, special requirements have been established. These are regulated in a separate regulation and the ISO standard “Clinical investigation of medical devices for human subjects – Good clinical practice”.

SOPs, templates, checklists, forms and logs.
Clinical interventional and observational studies

Interventional and observational studies that do not fall under the regulation for drug trials or medical device trials.

To SOP, templates, checklists, forms and logs.

Copyright © NorCRIN 2020 | post@norcrin.no | Web editor: Dan Andre Fosse