The process described is based on the Oslo University Hospital’s Research Procedure in eHåndboken (the hospital’s electronic manual). The procedures are currently available in Norwegian only:
- Helseforskningsprosjekter – REK (the Research Procedure)
- Ansvars- og myndighetsforhold i forskning (the Research Instruction)
- Melding om vesentlige endringer i helseforskningsprosjekt (Notification of significant changes to a health research project)
- Kliniske studier - Registrering og synliggjøring av studier og resultater (Procedure for registration of clinical trials)
The information can also be useful for researchers in other health care organisations planning a health research project, as many of the processes are generic.
Explanations of definitions and terms can be found in eHåndboken (Norwegian) and at NorCRIN (English/Norwegian).
See also Clinical trials involving drugs and medical devices.
Last updated 10/15/2024