Abstract: Based on the relevant provisions of the Standard for Good Clinical Practice, combining with the published at home and abroad about the quality of the quality risk management, risk-based quality management, risk management, and other related regulations, this paper summarizes the whole process of clinical trial risk-based quality management as well as the relevant regulations and suggestions for each process from the perspective of the sponsor. The aim is to provide theoretical basis for the next step of conducting risk-based quality management.

Key words: clinical trial, risk, quality management