阅读提示:1.以下的是ICH——GCP官网上文字的英文翻译整理,使用过程中,有些机翻的字词会稍有偏差,请自行脑补回来。 2. 每节末尾,包含部分的QUIZ ,因为quiz过了就不好重新看这个quiz了,另外有些quiz发现没写…
ICH—GCP 课程中文翻译+QUIZ参考 (完结于 22.12.20) 唐天瀛医生 上海中医药大学 中医学硕士 阅读提示: 1.以下的是ICH——GCP官网上文字的英文翻译整理,使用过程中,有些机翻的字词会稍有偏差,请自行脑补回来。 2. 每节末尾,包含部分的QUIZ ,因为quiz过了就不好重新看这个quiz了,… ...
Ⅷ、The information that must be provided in an informed consent document is specified in 45 CFR 46.116, 21 CFR 50.20, and ICH GCP 4.8.10. 8、 知情同意文件中必须提供的信息 在45 CFR 46.116、21 CFR 50.20和ICH GCP 4.8.10中有明确规定。 Ⅸ、The legal age for consent in most states is 1...
Dr. Band leaves the consent form for Alicia to read over, but she has a difficult time understanding the medical terms and can’t answer any of the consent quiz questions correctly. In the interest of saving time Dr. Band has her sign and date the consent form and enrolls her and promi...
Informed Consent of Trial Participants (ICH GCP 4.8.10) Both the informed consent discussion and the written informed consent form and any other written information to be provided to participants should include explanations of the following: