| Ⅳ期临床试验规范化管理研究 |
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| 引用本文： | 王继年,吴三兵,潘荣华.Ⅳ期临床试验规范化管理研究[J].南京医科大学学报(社会科学版),2016(3):184-187. |
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| 作者姓名： | 王继年 吴三兵 潘荣华 |
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| 作者单位： | 安徽医科大学第一附属医院教育处,安徽 合肥 230022,安徽医科大学第一附属医院教育处,安徽 合肥 230022,安徽医科大学马克思主义学院,安徽 合肥230022 |
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| 基金项目： | 国家社会科学基金项目“我国人类遗传资源安全监管法律制度研究”(13BFX128) |
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| 摘 要： | Ⅳ期临床试验在我国起步较晚,发展迅速,其研究意义和重要性也逐渐得到认可,但迅速发展的背后存在诸多应该防范的问题?明确Ⅳ期临床试验免费赠药问题?规范机构选择?扩大开展项目范围以及充分发挥机构及伦理委员会职能?强化Ⅳ期临床试验管理等方式,均可有效规范管理?
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| 关 键 词： | Ⅳ期临床试验 规范性 管理 |
| 收稿时间： | 2015/12/28 0:00:00 |
Research on standardized management of the phase IV clinical trial |
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| Wang Jinian,Wu Sanbing and Pan Ronghua.Research on standardized management of the phase IV clinical trial[J].Acta Universitatis Medicinalis Nanjing(Social Science),2016(3):184-187. |
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| Authors: | Wang Jinian Wu Sanbing and Pan Ronghua |
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| Institution: | Education Office, the First Affiliated Hospital of Anhui Medical University, Hefei 230022,Education Office, the First Affiliated Hospital of Anhui Medical University, Hefei 230022 and School of Marxism, Anhui Medical University, Hefei 230022 |
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| Abstract: | The phase IV clinical trial in China is making a rapid progress despite its late start and its research significance and importance have been recognized gradually. There exist many problems behind the rapid development, while these could be effectively managed and solved by the further definitude of free medicine in the phase IV clinical trial, selection of regulatory institutions, expansion of project scope, development of institutions and ethics committee functions and reinforcement of the IV clinical trial management. |
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| Keywords: | phase IV clinical trial standardability management |
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