4.5 Article Proceedings Paper

Principles of Good Clinical Practice (CCP) in clinical research

期刊

SCIENCE AND ENGINEERING ETHICS
卷 6, 期 1, 页码 71-77

出版社

OPRAGEN PUBLICATIONS
DOI: 10.1007/s11948-000-0025-z

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Good Clinical Practice (GCP); International Conference on Harmonisation (ICH); investigator; sponsor; ethics committee

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Good Clinical Practice is art international quality standard for conducting trials that involve participation of human subjects. Currently, the most widely accepted international document forming the base for GCP is the ICH Harmonised Tripartite Guideline for GCP, which defines in detail the responsibilities and obligations of parties engaged in clinical research. The purpose of this paper is to analyse how compliance with CCP provides protection of the trial subjects and assures quality and credibility of the data obtained.

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