Responsibilities of Investigators in Clinical Trials From Connt to Safety Reporting (GCP Principles and Standards)
Jenny Qin Abbott Vascular CIT March 31st, 2010
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• Regulation and Guidance ud in Clinical Rearch • Investigator’s Responsibilities-GCP Principle • Investigator’s Responsibilities-FDA Perspective
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Regulation and Guidance ud in Clinical Rearch
Clinical Rearch is conducted using the following regulations and guidelines;
FDA (US) vs. SFDA (China)
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Regulation and Guidance ud in Clinical Rearch
International Conference on Harmonization (ICH)：
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E6 –Good Clinical Practices (GCP)
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International ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects
Compliance of this standard ensures that the rights, safety, and well being of trial subjects are protected
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The Objective of ICH GCP guidelines is to provide a unified standard for the Europe, Japan and the United State to facilitate the mutual acceptance of clinical data by the regulatory authorities in the jurisdictions
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