Chapter I General Provisions §1
Chapter II Protection of Trial Subjects §16
Chapter III Ethics Committee §25
Chapter IV Investigator §30
Chapter V Sponsor
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
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