| 浅谈医院药物临床试验的质量管理 |
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| 引用本文： | 任茜,马忠英,翟小虎,徐焕春,牛静,强巧亮,崔艳艳,宋莲娜,廖悠悠,孙金,张薇,武倩文,文爱东.浅谈医院药物临床试验的质量管理[J].中国药师,2018(8):1453-1455. |
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| 作者姓名： | 任茜 马忠英 翟小虎 徐焕春 牛静 强巧亮 崔艳艳 宋莲娜 廖悠悠 孙金 张薇 武倩文 文爱东 |
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| 作者单位： | 空军军医大学第一附属医院（第四军医大学西京医院）药剂科 西安 710032 |
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| 摘 要： | 摘 要药物临床试验是新药研发的一个重要环节。本文在强调落实《药物临床试验质量管理规范》（GCP）的同时，结合医院药物临床试验机构的工作现状，针对在药物临床试验项目全程中存在的申办方资质不全、研究者能力和态度欠缺、药物临床试验机构监管不到位及伦理委员审查不全面的突出问题，进行分析并提出整改意见，旨在提高药物临床试验的质控管理水平和药物临床试验的质量。
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| 关 键 词： | 药物临床试验机构 临床试验 质量控制 |
| 收稿时间： | 2018/3/8 0:00:00 |
| 修稿时间： | 2018/5/13 0:00:00 |
Analysis of Quality Management of Hospital Drug Clinical Trials |
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| Ren Qian,Ma Zhongying,Zhai Xiaohu,Xu Huanchun,Niu Jing,Qiang Qiaoliang,Cui Yanyan,Song Liann,Liao Youyou,Sun Jin,Zhang Wei,Wu Qianwen,Wen Aidong.Analysis of Quality Management of Hospital Drug Clinical Trials[J].China Pharmacist,2018(8):1453-1455. |
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| Authors: | Ren Qian Ma Zhongying Zhai Xiaohu Xu Huanchun Niu Jing Qiang Qiaoliang Cui Yanyan Song Liann Liao Youyou Sun Jin Zhang Wei Wu Qianwen Wen Aidong |
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| Abstract: | ABSTRACTClinical trial is an important step of new drug research and development. Based on the GCP requirements and the current situation of hospital centre for drug clinical trial, the article focused on the prominent problems in the whole process of drug clinical trials including incompetent sponsors, disqualified attitude and ability of project investigators, regulatory vacancy of drug clinical trial centre and incomplete reviews of ethics committee. It was helpful to improve the level of hospital drug clinical trial centre and the quality of drug clinical trials by providing analysis and rectifications. |
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| Keywords: | Centre for drug clinical trial Clinical trial Quality control |
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