United States

Good Clinical Practice

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When handling biomaterials and related patient information, BioChain complies with the relevant regulations from the various governing bodies.

This includes the regulations on Good Clinical Practice (GCP) from the FDA, the Handbook For Good Clinical Research Practice from World Health Organization (WHO), and the Guideline for Good Clinical Practice from The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Good Clinical Practice includes approval of the protocol by the Investigation Review Board (IRB), the informed consent form for donors or participants, confidentiality/privacy of related information, and quality assurance in the process.