Medical and health research involving humans, human biological material or health data is governed by comprehensive national legislation, guidelines and regulations, as well as international laws and guidelines.
Use of national procedures (Standard Operating Procedures, SOPs) for individual investigators or trial personnel:
As an investigator or trial employee in a clinical trial of a medicinal product, you are responsible for following procedures that apply in your regional health authority, health trust or institution.
Check that your institution has implemented the procedures for clinical trials of medicinal products (LM), studies of other interventions (AI) and/or medical devices (MU) in its governing documents.
If you have any suggestions for changes or additions to SOPs or attachments, please use the “Feedback” button at the bottom of the page.
The SOP collection has been developed by a working group at NorCRIN with participants from all of Norway’s university hospitals, as well as representatives of the hospital pharmacies.
It is our wish that those of you who use the revised national procedures/guidelines for clinical research let us know if you find any errors or omissions. Please send your feedback to firstname.lastname@example.org.
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).
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”.
Studies that do not involve trials of medicinal products.
Clinical studies that do not involve testing medicinal products in humans are not covered by the same strict guidelines, but it may be appropriate to follow these guidelines for other types of studies as well.