研究者发起的临床研究质量管理常见问题及提升对策  

Common problems and improvement strategies of quality management in investigators-initiated clinical trials

作　　者：黄樱硕[1] 左旭 李悦[1] 邢荔函 郭水龙[1] 王振常[2] 张澍田[2] HUANG Ying-shuo;ZUO Xu;LI Yue;XING Li-han;GUO Shui-long;WANG Zhen-chang;ZHANG Shu-tian(Science and Technology Department,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;Office of the Hospital Administration,Beijing Friendship Hospital,Capital Medical University,Bejing 100050,China)

机构地区：[1]首都医科大学附属北京友谊医院科技处,北京100050 [2]首都医科大学附属北京友谊医院医院办公室,北京100050

出　　处：《中国新药杂志》2024年第16期1693-1698,共6页Chinese Journal of New Drugs

摘　　要：目的:分析研究者发起的临床研究(investigator-initiated clinical trials,IIT)在质量管理过程中的常见问题并探讨解决和提升策略。方法:通过归纳IIT的质量管理要点,分析IIT在质量管理过程中存在的常见问题,并针对这些问题提出解决建议。结果:IIT的质量控制要点主要包括流程规范性、受试者保护、数据管理和数据溯源、实施质量、样本管理等方面,通过汇总笔者所在医疗机构管理实践和监督检查中发现的问题可知,常见问题可分为研究者实施执行和主观认知2个层面。结合质量管理要点和常见问题,笔者建议通过设置科学统一的质控标准、落实分级质控、院内审查严格把关、建立完善培训体系等方法提高IIT管理质量。结论:质量控制对于提高IIT质量和规范性具有重要意义,医疗机构可结合质量管理要点和常见共性问题建立并优化内部质控管理体系,从而实现提升IIT规范化和质量的目标。Objective:To analyze the common problems in the quality control process of investigator-initiated clinical trials(IIT)and discuss the solutions and improvement strategies.Methods:By summarizing the key points of quality management of IIT,the common problems existing in the quality management process of IIT were analyzed,and suggestions were put forward to solve these problems.Results:The key points of quality control of IIT mainly include process standardization,subject protection,data management and data traceability,implementation quality,and sample management,etc.By summarizing the problems found in the management practice and supervision and inspection of the author's medical institution,the common problems could be divided into two levels,the implementation of the researcher and the subjective cognition.Combined with the key points and common problems of quality management,the author suggested that the quality of IIT management should be improved by setting scientific and unified quality control standards,implementing hierarchical quality control,strictly checking the internal review,and establishing and improving the training system.Conclusion:Quality control is of great significance to improve the quality and standardization of IIT,and medical institutions can establish and optimize the internal quality control management system based on the key points of quality management and common problems,so as to achieve the goal of improving the standardization and quality of IIT.

关 键 词：研究者发起的临床研究 质量管理 质量控制 监督检查 规范化 

分 类 号：R969.4[医药卫生—药理学]