天然药物临床试验总结报告撰写-CSCO.PDF

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2018-02-16 发布于天津
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天然药物临床试验总结报告撰写-CSCO.PDF

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天然药物临床试验总结报告撰写-CSCO

指导原则编号: 【Z 】 G C L 2 - 1 中药、天然药物临床试验总结报告的撰写原则（第二稿）二00四年三月十八日目录一、概述 ···················································4 ··5 二、结构与内容 ··········································· （一）报告封面 ·············································5 ·5 （二）签名页 ·············································· （三）报告目录 ·············································5 （四）缩略语 ··············································5 （五）伦理学问题 ···········································6 （六）报告摘要 ·············································6 ···········································7 （七）报告正文 ·· 1．前言 ····················································7 2．试验目的 ················································7 ·8 3．试验方法 ··············································· 3.1 试验设计 ·············································8 3.2 随机化设计 ············································8 ···········································8 3.3 设盲水平 ··· 3.4 研究对象 ·················