| 全程动态管理模式在我院药物临床试验质量控制中的应用 |
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| 引用本文： | 冯惠平,翁小香,刘艺群,郑小敏,王志榕.全程动态管理模式在我院药物临床试验质量控制中的应用[J].海峡药学,2020(1):212-213. |
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| 作者姓名： | 冯惠平 翁小香 刘艺群 郑小敏 王志榕 |
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| 作者单位： | 福建医科大学附属漳州市医院 |
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| 摘 要： | 为了提高药物临床试验质量,保障受试者的安全和权益,我院药物临床试验质量控制应用全程动态管理模式,建立了立项审查、项目启动、项目进行和结题等全过程的质量控制体系,以保证我院所承接的项目临床试验过程规范,数据真实、完整、可溯源。
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| 关 键 词： | 全程动态管理模式 药物临床试验 质量控制 应用 |
Application of Whole Dynamic Management Model in Quality Control of Drug Clinical Trials |
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| FENG Hui-ping,WENG Xiao-xiang,LIU Yi-qun,ZHENG Xiao-min,WANG Zhi-rong.Application of Whole Dynamic Management Model in Quality Control of Drug Clinical Trials[J].Strait Pharmaceutical Journal,2020(1):212-213. |
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| Authors: | FENG Hui-ping WENG Xiao-xiang LIU Yi-qun ZHENG Xiao-min WANG Zhi-rong |
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| Institution: | (Zhangzhou Municipal Hospital Affiliated to Fujian Medical University,Zhangzhou 363000,China) |
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| Abstract: | In order to improve the quality of drug clinical trials and protect the safety and rights of human subjects,the whole dynamic management model was applied in the quality control of drug clinical trials,and the whole process of quality control system were established,such as project review,project start-up,project execution and project conclusion,to ensure that the drug clinical trials process were standardized,and the reported trial data were accurate,complete,and verifiable from source documents. |
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| Keywords: | The whole dynamic management model Drug clinical trials Quality control Application |
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