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概念:知情同意 [2021/01/17 16:16]
老T 		概念:知情同意 [2022/02/28 08:40] (当前版本)
老T
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-===== 知情同意 / Informed Consent ===== +====== 知情同意 Informed Consent ======
  
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 +　　**知情同意**：指受试者被告知可影响其做出参加临床试验决定的各方面情况后，确认同意自愿参加临床试验的过程。该过程应当以书面的、签署姓名和日期的知情同意书作为文件证明。(([[法规:药物临床试验质量管理规范|药物临床试验质量管理规范]]. [[概念:国家药品监督管理局]]. 2020)) 
  
-==== 一、定 义 ==== +　　**Informed Consent**: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.(([[法规:ich-gcp|ICH GCP (E6(R2))]]. [[概念:ICH]]. 2016))
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-　　**知情同意**：指向受试者告知一项试验的各方面情况后，受试者自愿确认其同意参加该项临床试验的过程，须以签名和注明日期的知情同意书作为文件证明。(([[法规:药物临床试验质量管理规范|药物临床试验质量管理规范]]. （局令第3号）, 2003))+
  
-　　**Informed Consent**: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.(([[法规:ich-gcp|ICH-GCP]]. E6(R2), 2016)) 
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-==== 二、注意事项 ==== +===== 扩展阅读 =====
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-<font inherit/inherit;;inherit;;#FFFF00>（[[系统:待完成?do=backlink|待完成]]）</font>+
  
-\\+　　**1. FDA: [[法规:知情同意指南|知情同意指南（Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors）]]**
  
-==== 三、发展史 ==== 
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-<font inherit/inherit;;inherit;;#FFFF00>（[[系统:待完成?do=backlink|待完成]]）</font> 
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  • 概念/知情同意.1610900205.txt
  • 最后更改: 3年前
  • 由 老T