| 临床研究的伦理审查——跟踪审查 |
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| 引用本文： | 汪秀琴.临床研究的伦理审查——跟踪审查[J].中国医学伦理学,2011,24(5):677-678. |
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| 作者姓名： | 汪秀琴 |
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| 作者单位： | 南京中医药大学附属医院GCP中心,江苏南京,210029 |
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| 基金项目： | 江苏省医学人文社会科学基金资助(项目编号:JSYRKJ2010-B1-005) |
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| 摘 要： | 伦理委员会对临床研究的审查不只是局限于在研究开始前的审查，还包括研究开始以后的跟踪审查，包括复审、修正案审查、年度／定期跟踪审查、严重不良事件审查、违背方案审查、提前终止研究审查、结题审查。阐述了各类跟踪审查的操作程序和审查要点。
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| 关 键 词： | 临床研究 伦理委员会 跟踪审查 医学伦理 伦理审查 |
Ethic Review in Clinical Research: Ongoing Review |
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| WANG Xiu-qin.Ethic Review in Clinical Research: Ongoing Review[J].Chinese Medical Ethics,2011,24(5):677-678. |
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| Authors: | WANG Xiu-qin |
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| Institution: | WANG Xiu-qin(GCP Center,Affiliated Hospital of Nanjing University of Traditional Chinese Medicine,Nanjing 210029,China) |
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| Abstract: | Ethical review of clinical research by Ethics Committee is not just limited to the ethical review before the research,and also covers the ongoing review,review of resubmitted protocols,review of protocol amendments,annually or periodic review,adverse events review,protocol violation review;review of terminated prior to completion and final report review.In this paper,the operating procedure and ethical consideration of ongoing review was illustrated. |
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| Keywords: | Clinical Research Ethics Committee Ongoing Review Medical Ethics Ethical Review |
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