“Clinical trials of medicinal products on humans are an important but specific part of clinical research. Clinical trials are regulated by a separate regulation administered by the Norwegian Medical Products Agency, NOMA. All clinical trials must be pre-approved by both NOMA and REK KULMU (Committees for clinical trials of medicines and medical devices).”
Many scientific journals require that clinical trials be registered in ClinicalTrials.gov. Failure to register may result in the study not being accepted for publication. Clinical trials must be registered in ClinicalTrials.gov or equivalent databases before the study begins, that is, before the first participant is enrolled.
The project manager is responsible for updating project information when the status of a project changes, and at least every six months. ClinicalTrials.gov will also send email reminders when updates are due.
USN has an institutional account with ClinicalTrials.gov. Contact forskningsetikk@usn.no to request access.
The Research Council of Norway also requires that all clinical intervention studies it fully or partially funds, and that plan to include patients/participants in Norway, must be registered in ClinicalTrials.gov or another approved registry.
The Research Council follows the WHO’s definition of clinical intervention studies, which defines them as
"Studies/research projects that prospectively assign individuals or groups of people to one or more health-related interventions to evaluate the effects on health outcomes. Interventions may include, for example, medications, surgical procedures, devices, behavioural interventions, educational programs, quality improvement interventions, and change processes.”
Resources
- Home - ClinicalTrials.gov
- Clinical Trials - Helse Norge
- Requirements and guidelines for registration and disclosure of medical and health-related studies involving human participants, Norwegian Research Council
- Clinical Trials, National Research Ethics Committees
- Clinical Trials, World Health Organisation