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GOOD CLINICAL PRACTICES
The ethical and scientific quality of human clinical trials is subject to international standards set by the International Code of Harmonization (ICH) in the form of a series of guidelines known as Good Clinical Practice (GCP).
These guidelines are accepted worldwide and must be respected during any study involving humans. Adherence to GCP ensures the rights and safety of the volunteers and facilitates mutual acceptance of clinical data from one research centre to another.
The Main objectives of GCP are:
- to ensure the rights and the safety of volunteers participating in clinical studies
- to guarantee quality, ethics and the scientific aspects of studies carried out on humans
- harmonization of human clinical studies worldwide: Canada, the United States, the European Union, etc… according to the requirements of regulatory bodies
- standardization of test methods (HRIPT, 48 hr patch test, SPF testing of sunscreens…)
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