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).
Read moreMedical 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:
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 post@norcrin.no.
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).
Read moreFor 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”.
Read moreInterventional and observational studies that do not fall under the regulation for drug trials or medical device trials.
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