| 药物临床试验质量控制与质量保证体系探讨 |
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| 引用本文： | 谢洁琼.药物临床试验质量控制与质量保证体系探讨[J].中国药师,2015(7):1191-1194. |
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| 作者姓名： | 谢洁琼 |
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| 作者单位： | 国家食品药品监督管理总局高级研修学院 北京 100073 |
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| 摘 要： | 摘 要 通过解析和阐述我国药物临床试验各参与方申办者、研究者、临床试验机构及药品监督管理部门在试验质量控制与质量保证中的应有职责和存在问题，针对存在问题提出相应对策，为加强和完善我国药物临床试验质量控制与质量保证体系提出建议与期望。
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| 关 键 词： | 临床试验 质量控制 质量保证 |
| 收稿时间： | 2015/1/29 0:00:00 |
| 修稿时间： | 3/9/2015 12:00:00 AM |
Discussion on the Quality Control and Assurance Systems of Drug Clinical Trials |
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| Xie Jieqiong.Discussion on the Quality Control and Assurance Systems of Drug Clinical Trials[J].China Pharmacist,2015(7):1191-1194. |
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| Authors: | Xie Jieqiong |
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| Institution: | China Food and Drug Administration Institute of Executive Development, Beijing 100073, China |
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| Abstract: | ABSTRACT Through illuminating and analyzing the responsibilities and existing problems in the quality control and assurance of each participants involving in the conduction of clinical trials (including sponsors, investigators, clinical trial bases and drug regulatory administration), the relative countermeasures were put forward, and some proposals and expectations were also provided to strengthen and improve the quality control and assurance systems of drug clinical trials in China. |
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| Keywords: | Clinical trials Quality control Quality assurance |
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