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中国临床研究英文版:2023,3(9):1412-1416
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基于医院信息系统的临床试验受试者免费检查系统设计与实践
(东南大学附属中大医院临床试验机构办公室,江苏 南京 210009)
Design and practice of free-examination of clinical trial subjects based on hospital information system
(Drug Clinical Trial Institution, Zhongda Hospital Affiliated to Southeast University, Nanjing, Jiangsu 210009, China)
摘要
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Received:February 10, 2023   Published Online:September 19, 2023
中文摘要: 目的 探讨临床试验受试者免费检查系统用于医院临床试验工作的效果。方法 基于医院信息系统(HIS),设计临床试验受试者免费检查系统,并比较系统应用前后的效果。结果 与临床试验受试者免费检查系统应用前比较,减少了检查相关的方案违背数量、缩短了财务结算平均时长,提高了临床试验各方工作效率与满意度。结论 本院临床试验受试者免费检查系统操作便捷,可提高临床试验的管理水平和工作效率。
Abstract:Objective To explore the effectiveness of free-examination system for clinical trial subjects in hospital clinical trials. Methods Based on the hospital information system, a free-examination system for clinical trial subjects was designed and implemented, and the effects were compared before and after the application of the system. Results After the application of the free-examination system for clinical trial subjects, the number of protocol violations related to examinations and the average time of financial settlement reduced, so the work efficiency and satisfaction of all parties involved in clinical trials were improved compared with those before application. Conclusion For the participants in this clinical trial, the free-examination system is easy to operate and can improve management level and work efficiency of the clinical trial.
文章编号:     中图分类号:R95    文献标志码:B
基金项目:江苏省药品监督管理局科研计划课题(202106);中关村玖泰药物临床试验技术创新联盟GCP专项(LMZX-LC004-2)
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