显示页面修订记录反向链接回到顶部 本页面只读。您可以查看源文件,但不能更改它。如果您觉得这是系统错误,请联系管理员。 CKG 可视编辑器 ====== 知情同意 Informed Consent ====== \\ **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)) \\ ===== 扩展阅读 ===== **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)]]** \\ 概念/知情同意.txt 最后更改: 2年前由 老T