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Chapter

Title： Regulations for Good Clinical Practice CH
Category： Ministry of Health and Welfare（衛生福利部）
Chapter I General Provisions § 1
Chapter II Protection of Trial Subjects § 16
Chapter III Ethics Committee § 25
Chapter IV Investigator § 30
Chapter V Sponsor § 40
I. General Rules § 40
II. Quality Assurance and Quality Control § 49
III. Data Handling and Record Keeping § 53
IV. Management of Investigational Product(s) § 62
V. Monitoring § 73
VI. Audit § 80
Chapter VI Application and Assessment of Clinical Trials § 83
Chapter VII Conduction of Clinical Trials § 89
I. Clinical Trial Protocol § 89
II. Investigational Products § 92
III. Records and Reports § 98
IV. Suspension and Termination of a Trial § 112
V. Multicenter Trials § 117
Chapter VIII Supplemental Provisions § 122