Regulations and guidelines

NorCRIN’s reference document provides an overview of current national and international laws, regulations and the ICH Guideline for Good Clinical Practice (ICH GCP) that apply to clinical trials in Norway. The reference document applies to clinical trials conducted in Norway.

Other links:

Tips and advice for applicants for clinical trials of medicinal products in humans

The Norwegian Medicines Agency (SLV) website – about clinical trials

WHO Handbook for Good Clinical Practice

ICH E8 General Considerations for Clinical Trial

The Good Clinical Data Management Practices (GCDMP) standard