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…
二、学习并通过quiz 流程:GCP课程有12个模块,每个模块学好后参加quiz,通过,再学下面一个。全部quiz通过,就可以拿证了。 具体课程可以直接进入,这个阶段就不用梯子了。quiz的score需要到80以上,才能通过。 点击进入一个modules,开始学习,学习好后右上角take quiz,全部通过,右上角certification可以下载证书。 因为ICH-...
ICH GCP Test with Questions and Answers 2023 •1. Neither the investigator nor the trial staff should ___ or unduly influence a subject to participate or to continue to participate in a trial. oA. Convince oB. Coerce oC. Compel oD
The protection of subject rights and safety, married with the output of robust, trustworthy clinical data, is the key objective of GCP, and both sponsors and investigators have their own set of responsibilities within ICH's E6 GCP framework. Only about a third of FDA-regulated drugs make it ...
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...
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:
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