Abstract: Objective：From the perspective of practical application， through the research of HACCP method， and combined with the example of risk assessment to steps or departments in on-site vaccine clinical trial， give suggestion and advice to establish the strategy of Risk-based monitoring in vaccine clinical trial. Methods： Using the method of literature research and Combined with the instance， analyzes and draws lessons from the successful experience. Results and Conclusion： According to the characteristics and regulations of clinical trials， Chinese vaccine development company should assess risk of each step or department in on-site clinical trials. According to the evaluation results， reasonably establish and implement monitoring strategies so as to ensure scientificalness， normalization， reality and reliability of clinical trial. In addition， this method of the paper can also be applied to all drug clinical trials to effectively ensure the quality of clinical trials.