All researchers are obliged to follow the very detailed principles/rules of the International Conference on Harmonization—Good Clinical Practice (GCP). GCP is an international ethical and

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.

GCP stands for Good Clinical Practice. GCP is a guide to international ethical and scientific quality standards in clinical trials. The GCP guideline applies to all persons involved in a study. In addition to patient safety, GCP ensures that data and results from clinical trials are valid and reproducible. Goals of the ICH GCP Guideline

Good clinical practice (GCP) is defined as a "standard for the design, conduct, performance, monitoring, auditing, recording, analyzing and reporting of clinical trials." It provides assurance that the obtained data and reported results are credible and accurate.

The purpose of this paper is to analyse how compliance with GCP provides protection of the trial subjects and assures quality and credibility of the data obtained. Good Clinical Practice is an international quality standard for conducting trials that involve participation of human subjects. 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) . 9dm7T.