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*****************************************************, is a tripartite agreement between the United States, the European Union, and Japan. The ****has stipulated what are known as “Good Clinical Practices” (GCPs) that describe mutually agreeable standards for the conduct of clinical research in these countries.
What is “Good Clinical Practice?”
As stated in the introduction to the ****GCP guideline E6: “Good Clinical Practice is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The objective of this *** GCP Guideline is to provide a unified standard for the European Union, Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.”
In other words, when clinical trials are conducted in compliance with GCP standards, regulatory agencies in the United States, the European Union and Japan have agreed to accept data collected from clinical trials in each other’s countries when considering approval of new pharmaceutical products or medical devices.
The**** GCP standards now cover 17 countries, with other countries beginning to adopt*****GCP.
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