临床试验听听看 ▎ICH GCP 4.8.14

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法律不禁止该试验

e) The approval/favourable opinion of the IRB/IEC is expressly sought on the inclusion of such subjects, and the written approval/ favourable opinion covers this aspect.

明确的寻求IRB/IEC对接纳这些受试对象的批准/赞成意见;书面的批准/赞成意见同意接纳这些受试对象。

Such trials, unless an exception is justified, should be conducted in patients having a disease or condition for which the investigational product is intended. Subjects in these trials should be particularly closely monitored and should be withdrawn if they appear to be unduly distressed.

除非被证明是一个例外，这类试验应当在具有预期适用试验用药品的疾病或状况的病人中进行。这些试验中受试对象应当受到特别的密切检查，如果他们显得过分痛苦，应当退出试验。

主要 “言” 究者简介：

美人驴： 药物临床试验网会员(1439498788 同QQ)，运营临床试验微信公众号 “临听” 和日常生活微信公众号 “WeListen” 。努力成为临床试验圈英语教得最好、英语老师圈最会做临床试验的斜杠青年。

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