关键词: font-size:medium, ">临床试验；质量管理；质量控制；组织和管理

Abstract: Objective：To describe the operating procedures of quality control inspection for third-party quality in clinical trials and investigate the role of third-party quality control inspection in thequality management of clinical trial . Methods：We summarize the working procedures of quality control inspections for third-party experts on clinical trial and analyzed the advantage of third-party quality control inspections in clinical trial management. Results：The independent experts with rich experience are pivotal for the third-party quality inspection in clinical trial. Independent experts obtained the support of sponsor/CRO and clinical trial institution can promote the quality of clinical trial， the efficiency of management， the level of clinical trial investigators， and the communication of the industry of clinical trial. Conclusion：The third-party quality control inspection of clinical trials can further enhance the monitoring on clinical trial， improve the quality of clinical trial projects， and promote the sustainable development of clinical trial institutions and industries.

Key words: Clinical trials, Quality management, Quality control, Organization and administration