| 浅谈伦理委员会质量监查 |
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| 引用本文： | 张维,王志睿,乔逸,文爱东. 浅谈伦理委员会质量监查[J]. 中国医学伦理学, 2012, 25(1): 87-88 |
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| 作者姓名： | 张维 王志睿 乔逸 文爱东 |
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| 作者单位： | 1. 第四军医大学西京医院药剂科,陕西西安,710033
2. 中国人民解放军总后勤部上海干休所,上海,200437 |
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| 摘 要： | 从伦理委员会质量监查员的确定,临床试验研究的监查程序以及监查结果三个方面阐述了伦理监查的全过程,提出监查员应当具有医药知识和临床经验,应当按程序到研究点去核查临床试验,研究文件和有关资料.伦理委员会质量监查有助于全面监查严重不良事件,改善医患关系,促进临床实验顺利地进行.
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| 关 键 词： | 伦理委员会 监查员 伦理质量监查 医患关系 临床试验 |
On Quality Monitoring by Ethics Committee |
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| ZHANG Wei , WANG Zhi-rui , QIAO Yi , WEN Ai-dong. On Quality Monitoring by Ethics Committee[J]. Chinese Medical Ethics, 2012, 25(1): 87-88 |
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| Authors: | ZHANG Wei WANG Zhi-rui QIAO Yi WEN Ai-dong |
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| Affiliation: | 1(1 Department of Pharmacy,Xijing Hospital,the Fourth Military Medical University,Xi’an 710033,China; 2 Shanghai Retired Cadres of the General Logistics Department,Shanghai 200437,China) |
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| Abstract: | This article describes the whole process of the ethics monitoring from the following three aspects: the determination of the ethics committee quality monitor;monitoring procedure of the clinical trials research;and its monitoring results.It also puts forward that the monitor should have medicine knowledge and experience on clinical trials,should follow the procedures to check out the clinical trials,documents and relevant materials at the research spot.Standardized monitoring will help to comprehensive monitoring the serious adverse events,to improve the doctor-patient relationship,to make sure the clinical trials go on wheels and end well. |
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| Keywords: | Ethics Committee Monitors Ethical Quality Monitoring Doctor-patient Relationship Clinical Trials |
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