Risk assessment refers to the work of quantitative assessment of various aspects of the impact and the possibility of loss that a risk event may cause before or after the occurrence of a risk event. For clinical research, due to its exploratory characteristics, the research project itself has different degrees of uncertainty, and it is necessary to evaluate the risks of the research at the project management level before the implementation of the research project, and at the same time, it is necessary to evaluate the possible impacts and losses caused by risk events that have occurred. From the perspective of ethical management and subject protection, it is also necessary to identify possible risk links in the implementation of research projects and evaluate their risk degree. This is especially true for clinical research in the field of pediatrics. All stakeholders in clinical research need to fully identify the risks of research projects and make a more complete evaluation, so as to ensure the quality and scientificity of clinical research projects, while ensuring that the interests of all parties are not harmed.