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