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概念:知情同意 [2022/02/25 04:14]
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**：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（GCP）]]. [[概念:国家药品监督管理局]]. 2020)) +　　**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)) 
  
 　　**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)) 　　**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))
  • 概念/知情同意.1645762453.txt
  • 最后更改: 2年前
  • 由 老T