基于风险防控的药物临床试验机构监督检查关注点分析  

Risk Based Analysis of Supervision and Inspection Concerns in Drug Clinical Trial Institutions

作　　者：王健 冯巧巧 李超 张建永 申洪泮 WANG Jian;FENG Qiao-qiao;LI Chao;ZHANG Jian-yong;SHEN Hong-pan(Shandong Center for Food and Drug Evaluation and Inspection)

机构地区：[1]山东省食品药品审评查验中心

出　　处：《中国食品药品监管》2025年第2期136-141,共6页China Food & Drug Administration Magazine

摘　　要：目的:分析药物临床试验机构监督检查关注点,提出风险防控措施,为药品科学监管提供技术支撑。方法:基于在监管实践中实施应用《药物临床试验机构监督检查办法(试行)》《药物临床试验机构监督检查要点及判定原则(试行)》,梳理分析药物临床试验机构监督检查关注点,识别相关风险点,明确风险警示,提出风险防控措施。结果与结论:基于风险防控的药物临床试验机构监督检查是药品科学监管的重要手段,对于提升检查效能、科学利用监管资源、提升药物临床研究水平等具有积极促进作用。Objective:This article aims to analyze the key concerns in the supervision and inspection of drug clinical trial institutions,propose risk prevention and control measures,and provide technical support for scientific drug regulation.Methods:In regulatory practice,the Measures for Supervision and Inspection of Drug Clinical Trial Institutions(Trial)and the Key Points and Judgment Principles for Supervision and Inspection of Drug Clinical Trial Institutions(Trial)were applied.Based on these,the supervision and inspection concerns were sorted and analyzed,relevant risk points identified,risk warnings clarified,and control measures proposed.Results and Conclusion:Risk-based supervision and inspection of drug clinical trial institutions is an important means of scientific drug regulation.It plays a positive role in improving inspection efficiency,utilizing regulatory resources more effectively,and enhancing the level of drug clinical research.

关 键 词：药物临床试验机构 监督检查 风险防控 备案管理 主要研究者 

分 类 号：R95[医药卫生—药学]