2020-2022年某院药物临床试验项目质量控制报告分析OA
Analysis of Quality Control Reports of Drug Clinical Trial Projects in a Hospital from 2020 to 2022
目的 为药物临床试验机构完善质量控制体系提供参考.方法 收集 2020 年 4 月至 2022 年 12 月淮安市第二人民医院药物临床试验机构办公室质量控制报告并进行统计和分析.结果 共纳入 93 份报告,汇总质量控制问题 8 类、386 次,主要为原始文件记录问题(116 次,30.05%)、电子数据采集系统数据录入问题(73 次,18.91%)、试验用药品问题(59 次,15.28%)、不良事件问题(43 次,11.14%)、检查检验问题(35 次,9.07%)、文件资料问题(21 次,5.44%)、方案违背(18 次,4.66%)、知情同意问题(13 次,3.37%)及其他问题(8 次,2.07%).结论 临床试验机构应重视项目运行中各个环节的监督检查,加强研究者培训,提高研究者执行《药物临床试验质量管理规范》的意识,不断提高临床试验的质量.
Objective To provide reference for drug clinical trial institutions to improve their quality control systems.Methods The quality control reports from the Office of Drug Clinical Trial Institution of The Second People's Hospital of Huai'an from April 2020 to December 2022 were collected,statistically analyzed and summarized.Results A total of 386 times of quality control issues were summarized from 93 reports,mainly involving eight categories:original document recording issues(116 times,30.05%),electronic data capture system data entry issues(73 times,18.91%),investigational product issues(59 times,15.28%),adverse event issues(43 times,11.14%),examination and test issues(35 times,9.07%),documentation issues(21 times,5.44%),protocol deviations(18 times,4.66%),informed consent issues(13 times,3.37%)and other issues(8 times,2.07%).Conclusion Clinical trial institutions should attach importance to the supervision and inspection of each link during project implementation,strengthen investigator training,improve investigators'awareness of implementing Good Clinical Practice,and continuously enhance the quality of clinical trials.
薛乐刚;李海伦;葛秋;杨蓉;李江南;丁莹;李大伟
江苏省淮安市第二人民医院,江苏 淮安 223002江苏省淮安市第二人民医院,江苏 淮安 223002江苏省淮安市第二人民医院,江苏 淮安 223002江苏省淮安市第二人民医院,江苏 淮安 223002江苏省淮安市第二人民医院,江苏 淮安 223002江苏省淮安市第二人民医院,江苏 淮安 223002南京医科大学第一附属医院,江苏 南京 210000
医药卫生
药物临床试验质量控制报告统计分析药事管理
drug clinical trialquality control reportstatistical analysispharmaceutical administration
《中国药业》 2026 (18)
21-24,4
江苏省卫生健康委科研项目[H2019062]江苏省医院协会医院管理创新研究课题[JSYGY-3-2024-107].
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