No. 17 of 2024 Announcement of the State Administration for Market Regulation on the Release of the Quality Management Standards for Clinical Trials of Special Medical Purpose Formula Foods.

These Standards are formulated to standardize the clinical trial process of formula foods for special medical purposes, ensure the scientific, truthful, and reliable data and results, and protect the safety and rights of participants.
The Standards outline the quality management specifications for clinical trials of special medical purpose formula foods. It covers various aspects of clinical trial management, including data collection, statistical analysis, and quality assurance measures. Key points highlighted in the document include the need for a detailed clinical trial protocol that outlines the study design, observation indicators, data management procedures, and statistical analysis methods. It stresses the importance of adhering to ethical standards, ensuring participant safety, and maintaining data integrity throughout the trial process. The document also discusses the role of monitoring officers in overseeing the trial to ensure compliance with the protocol and standard operating procedures. It emphasizes the proper storage and handling of trial samples, as well as the importance of accurate record keeping and documentation. Furthermore, the document outlines the requirements for reporting clinical trial results.