WHO Handbook Good Clinical Research Practice
Clinical research is necessary to establish the safety and effectiveness of specific health and medical products and practices. Much of what is known today about the safety and efficacy of specific products and treatments has come from randomized controlled clinical trials that are designed to answer important scientific and health care questions. Randomized controlled trials form the foundation for “evidence-based medicine”, but such research can be relied upon
only if it is conducted according to principles and standards collectively referred to as “Good Clinical Research Practice” (GCP). This handbook is issued as an adjunct to WHO’s “Guidelines for good clinical practice (GCP) for trials on pharmaceutical products” (1995),
and is intended to assist national regulatory authorities, sponsors,
investigators and ethics committees in implementing GCP for industry sponsored,
government-sponsored, institution-sponsored, or investigator-initiated clinical research.
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