FAIRsharing record for: WHO Guidelines for good clinical practice (GCP) for trials on pharmaceutical products

This FAIRsharing record describes: The purpose of these Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO TRS 850 - Annex 3) is to set globally applicable standards for the conduct of such biomedical research on human subjects. They are based on provisions already promulgated in a number of countries, including Australia, Canada, European Community countries, Japan, Nordic countries (Denmark, Finland, Iceland, Norway and Sweden) and the United States. These provisions inevitably vary somewhat in content and emphasis, but all are consonant with regard to the prerequisites to be satisfied and the principles to be applied as a basis for assuring the ethical and scientific integrity of clinical trials. Indeed, they have provided a formal basis for mutual recognition of clinical data generated within the respective countries.