세계보건기구(WHO)에서 2002년 제작한 "Handbook for Good Clinical Research Practice"입니다. (총 129쪽)
[목차]
Preamble 1
Introduction 3
Overview of the Clinical Research Process 8
WHO Principles of GCP 21
Principle 1: Ethical Conduct 21
Principle 2: Protocol 27
Principle 3: Risk Identifi cation 35
Principle 4: Benefi t-Risk Assessment 42
Principle 5: Review by Independent Ethics Committee/
Independent Review Board 48
Principle 6: Protocol Compliance 54
Principle 7: Informed Consent 59
Principle 8: Continuing Review/Ongoing Benefi t-Risk
Assessment 72
Principle 9: Investigator Qualifi cations 82
Principle 10: Staff Qualifi cations 87
Principle 11: Records 92
Principle 12: Confi dentiality/Privacy 103
Principle 13: Good Manufacturing Practice 110
Principle 14: Quality Systems 115
References: 121
Documents on CD 121
Other documents cited in the Handbook 122
Related documents 123
National Good Clinical Practice and Other Guidelines 124
Acknowledgements 125
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