GOOD CLINICAL RESEARCH PRACTICE (GCP)

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 have 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). A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.

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 have 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). A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.