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AI Guideline og vedlegg
AI Guideline for Clinical Interventional Studies v.1.0
APPENDIX TO PROCEDURE
Interventions that do not involve testing medicinal products will, as a general rule, be covered by the Norwegian Act on Medical and Health Research (the Health Research Act) and require prior approval from the Regional Committee for Medical and Health Research Ethics (REK). When planning a medical and health research project, you should familiarise yourself with the requirements that apply to this type of research. A good starting point is to read the following:
A protocol template can be found in the “Guideline for Clinical Interventional Studies”. A good approach to protocol writing is also to use published protocols as a starting point:
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