Abstract: Objective To provide reference for pediatric drug clinical trial risk management. Methods Based on the theory of risk management, literature review and practical work experience, the risk factors and risk control measures of pediatric drug clinical trials were summarized. Results Risk identification and risk assessment are carried out from project assessment risk, such as Investigator's Brochure with results from young animals, data of adult and foreign children;Sponsors manage risk; Manage risks from professional teams, such as principal investigators with extensive pediatric clinical experience; the implementation risk of clinical trials, the management risk of Investigational Medical Product and biological sample,as well as the management system risk.Through risk aversion; Risk mitigation, such as enhanced quality control of clinical trials and enhanced management of clinical trial institutions; Risk transfer, such as the purchase of insurance, clear contract compensation and rights protection clauses and other measures to control the risk. Conclusion Through risk identification and assessment of risk factors in pediatric drug clinical trials, corresponding measures are adopted for risk management, so as to reduce and avoid the occurrence of clinical trial risks and protect the rights and interests of subjects and Investigators.

Key words: pediatric drug clinical trials, risk identification, risk control