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知情同意 / Informed Consent
一、定 义
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。1)
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.2)
二、注意事项
(待完成)
三、发展史
(待完成)
1)
药物临床试验质量管理规范. (局令第3号), 2003