【摘要】 目的：探讨优化临床试验质量管理体系的新举措新方法，持续改进临床试验质量，保护受试者的权益和安全。方法：运用头脑风暴法、鱼骨图、PDCA循环等管理工具对某地市级医院药物临床试验机构临床试验质控问题进行归类汇总，从研究机构、研究者、申办者、受试者等多角度分析原因，在体系建设、责任落实、能力提升、过程管理等方面制定相应的制度体系和干预措施。结果：通过优化临床试验质量管理体系建设，该院临床试验质量显著提升，缺陷发生率整体下降，其中受试者筛选入组、安全性事件管理、临床试验源文件及数据记录、试验用药品管理等不规范问题发生率均有所下降。结论：新政策背景下，药物临床试验机构应通过压实主要研究者责任，严格履职能力考核；强化研究者能力提升，规范GCP质量考核；优化质控管理制度，健全风险管理模式等措施，全面保障临床试验质量。更多还原

【Abstract】 Objective: To explore innovative measures and methods to optimize the clinical trial quality management system, in order to achieve continuous improvement in the quality of clinical trials, safeguard the rights and safety of participants. Methods: Management tools such as brainstorming sessions, fishbone diagrams, and PDCA(Plan-Do-Check-Act) cycles were employed to classify and summarize issues related to clinical trial quality control in a drug clinical trial institution of a municipal-level hospital. The study analyzed root causes of the problem from multiple perspectives including research institutions, researchers,sponsors and subjects. Corresponding systems and intervention strategies were developed focusing on system construction, accountability implementation, capability enhancement, and process management. Results: By optimizing the clinical trial quality management system, the quality of clinical trials in this hospital has significantly improved, and the overal incidence of abnormal problems-such as subject screening errors,safety event management deficiencies, inadequacies in source documentation/data recording practices, and experimental drug management was notably reduced. Conclusion: In light of new policy developments, drug clinical trial institutions should enhance their quality management systems by reinforcing accountability and performance assessments among principal investigators, improving researcher capabilities while standardizing Good Clinical Practice(GCP) evaluations, refining the overall quality control framework and perfecting risk management models, to comprehensively ensure the quality of clinical trials.更多还原