| 病例报告表的设计及其常见问题分析 |
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| 引用本文： | 李庆娜,陆芳,安丰华,高蕊.病例报告表的设计及其常见问题分析[J].金属学报,2013,18(8):901-906. |
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| 作者姓名： | 李庆娜 陆芳 安丰华 高蕊 |
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| 作者单位： | 1.中国中医科学院西苑医院GCP中心,北京 100091;2.山东省胶南市中医医院医务科,青岛 266400,山东 |
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| 基金项目： | “重大新药创制”中药新药临床评价研究技术平台建设-创新药物研究开发技术平台建设(2012ZX09303- 010-002);“中医药行业科研专项”中医慢病临床科研体系及其成果转化应用模式研究项目(201107006);“中医药行业科研专项”慢性胃炎中医药防治技术及规范的转化应用研究项目(201007006);全国中医医疗与临床科研信息,共享的推广应用研究(201207001-02) |
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| 摘 要： | 病例报告表(Case report form,CRF)是临床试验中收集药物有效性和安全性数据的载体,其设计是否科学严谨直接关系到整个临床试验的成败。本文简介了CRF的设计过程及临床数据采集标准(Clinical data acquisition standards harmonization,CDASH),并对临床试验CRF设计中容易出错的模块和其他常见问题进行分析和说明。
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| 关 键 词： | 病例报告表 设计 临床数据采集标准 模块 |
| 收稿时间： | 2012-12-26 |
| 修稿时间： | 2013-01-22 |
Analysis of the design of a case report form and the common problems |
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| LI Qing-na,LU Fang,AN Feng-hua,GAO Rui.Analysis of the design of a case report form and the common problems[J].Acta Metallurgica Sinica,2013,18(8):901-906. |
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| Authors: | LI Qing-na LU Fang AN Feng-hua GAO Rui |
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| Affiliation: | 1.Gcp Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China;2.Medical Section, Jiaonan Traditional Chinese Medicine Hospital, Qingdao 266400, Shandong, China |
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| Abstract: | Case report form is designed to record drug efficacy and safety data in clinical trial. Whether or not the design of it is scientific and rigorous directly affects the success of a clinical trial. In this article, how to develop a CRF and the content of clinical data acquisition standards harmonization(CDASH) will be briefly introduced. Then, some modules of the CRF, which are often wrongly designed, and other common problems in designing the CRF will be analyzed and illustrated. |
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| Keywords: | Case report form Design Clinical data acquisition standards harmonization Module |
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