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两侧同时换到之前的修订记录 前一修订版 后一修订版 | 前一修订版 | ||
概念:知情同意 [2022/02/25 03:44] 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: | + | **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: |
**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' | **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' |