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This standard applies to the quality management of the entire process of clinical trials of foods for special medical purpose, including protocol design, organizational implementation, data management and statistical analysis, as well as the summarization and reporting of clinical trial results.
Contents
Chapter 1 General Rules
Chapter 2 Duty Requirements
Chapter 3 Clinical Trial Protocol
Chapter 4 Clinical Trial Implementation
Chapter 5 Data Management and Statistical Analysis
Chapter 6 Clinical Trial Report
Chapter 7 Terms and Definitions
Chapter 8 Supplementary Provision
Laws & Regulations
