The Good Clinical Laboratory Practices (GCLP) concept possesses a unique quality, as it embraces both the research and the clinical aspects of GLP. The development of GCLP standards encompasses applicable portions of 21 CFR parts 58 (GLP) and 42 CFR part 493 (Clinical Laboratory Improvement Amendments -CLIA) .
GCP is the agreed international standard for conducting clinical research. Good Clinical Practice Training is needed for researchers conducting Clinical Trials of Investigational Medicinal Products (CTIMPs).
The following resources are provided to help investigators, sponsors, and contract research organizations who conduct clinical studies on investigational new drugs comply with U.S. law and
Good Clinical Research Practice (GCP) is a process that incorporates established ethical and scientifi c quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects. Compliance with GCP provides public assurance that the rights, safety, and well-being of research
Abstract. This chapter looks at the purpose and history of the development of good clinical practice (GCP). The international conference on harmonisation (ICH) GCP is the international quality standard for conducting clinical research to ensure the rights and well-being of patients are protected and the resulting data are valid.
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