Guidelines
When executing clinical trials, Novo Nordisk is committed to complying with national regulations in the countries where the trials are performed as well as a number of international declarations and guidelines.
Two fundamental international guidelines form the basis for drug development worldwide:
The Declaration of Helsinki
The objective of the Declaration of Helsinki is to ensure the rights of trial participants. This declaration was developed and signed by all countries in 1964.
Good Clinical Practice (GCP)
All Novo Nordisk clinical trials are performed in accordance with the Good Clinical Practice (GCP) guideline to ensure the rights, safety and well-being of the trial participants. The GCP guideline was drawn up by the International Conference on Harmonisation (ICH), consisting of health authority representatives from Europe, the US and Japan and the pharmaceutical industry.
The ICH guidelines ensure that clinical trials are conducted according to the same principles all over the world.
Other guidelines
Belmont Report
Code of Federal Regulation (US)
EU Clinical Trials Directive
Nuremberg Code
UNESCO