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PART IV GLOBAL REGULATIONS FOR GOOD CLINICAL PRACTICES (GCP)

INTRODUCTION The Good Clinical Practices (GCPs) regulations section (21 CFR 312 Subpart D) in the Code of Federal Regulations, International Conference on Harmonization (ICH E6) Guideline for GCP and the European Clinical Trial Directive (2001/20/IEC on GCP), outlines the responsibilities and obligations of the clinical investigator, the drug sponsor, and the clinical trial monitor in the conduct of investigational new product development. In addition to the regulated conduct of clinical investigations, each participant has a moral and ethical responsibility for the safety of subjects who voluntarily participate in clinical trials. GCP has long been the norm in the United States for the investigator, as included in the Form FDA 1572. However, the first proposed regulations pertaining to investigators, sponsors, and monitors were circulated in U.S. Federal Register in 1977 and 1978. In 1987, 10 years later, GCP were published as final regulations in the Code of Federal Regulations. In ICH guidelines, these were proposed in 2001 and in the European Directives finalized in 2004 as regulations in the EU. Today, investigators, sponsors, and monitors are obligated by law to follow GCP.