| 我国药物临床试验信息化建设初探 |
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| 引用本文： | 丁倩,曹彩. 我国药物临床试验信息化建设初探[J]. 中国新药杂志, 2012, 0(7): 722-727 |
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| 作者姓名： | 丁倩 曹彩 |
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| 作者单位： | 首都儿科研究所;国家食品药品监督管理局药品认证管理中心 |
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| 基金项目： | 国家重大新药创制科技重大专项(2009ZX09309-003) |
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| 摘 要： | 我国药物临床试验机构经过多年的发展,临床试验的试验条件、质量有了一定的改善,但与发达国家相比,还存在着很多不足,应用信息化管理可以有助于提高药物临床试验质量管理。文中对药物临床试验信息化管理的优势和国内外药物临床试验信息化管理情况进行了介绍,同时对实现我国药物临床试验信息化建设进行了讨论,并提出了需注意的问题。
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| 关 键 词： | 临床试验 信息化 管理 |
Information management in clinical trials |
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| DING Qian,CAO Cai. Information management in clinical trials[J]. Chinese Journal of New Drugs, 2012, 0(7): 722-727 |
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| Authors: | DING Qian CAO Cai |
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| Affiliation: | 1 Capital Institute of Pediatrics,Beijing 100020,China;2 Certification Center, State Food and Drug Administration,Beijing 100061,China) |
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| Abstract: | During the several years,the development in Chinese clinical trials has been improved in the research conditions and quality.In comparison with the clinical trials in the developed countries,there are still many insufficiencies.Application of information management could improve the quality control of drug clinical trials.In this paper,we introduced the advantages of information management in clinical trials,and the informationalization of clinical trials in China and overseas.Meanwhile,we discussed the construction of information management in clinical trials in China and put forward the notice of information system in clinical trials. |
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| Keywords: | clinical trials informationalization administration |
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