This standard is to specify the overall process of the applicant to conduct clinical trial of foods for special medical purpose, including formulation of clinical trial plan, protocol design, organization implementation, monitoring, record, rights and interests and safety guarantee of subjects, quality control, data management and statistical analysis and summary and report of the clinical trial.
Contents
Chapter I General Rules
Chapter II Implementation Condition of Clinical Trial
Chapter III Duty Requirements
Chapter IV Guarantee of Rights and Interests of Subjects
Chapter V Contents of Clinical Trial Protocol
Chapter VI Management of Investigational Product
Chapter VII Quality Assurance and Risk Management
Chapter VIII Data Management and Statistical Analysis
Chapter IX Contents of Clinical Trial Final Report
Chapter X Others
Chapter XI Supplementary Provisions
Original regulatory document
