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让我们一起从头开始学习ICH GCP原文(11)【研究者..._知乎
14 4.9 Records and Reports ADDENDUM 4.9.0 The investigator/institution should maintain adequate and accurate source documents and trial records that include all pertinent observations on each of the site's trial subjects. Source data should be attributable, legible, contemporaneous, original, accurate, and complete. Changes to source data should be traceable, should not obscure the original entry, and should be explained if...
ICH-GCP试题答案及解析_知乎
10 试题来源美国Pharma School Online Learning,如果对答案有异议,欢迎后台留言相互探讨. QuestionNumber: 1 of 10 According to ICH GCP what are the absolute minimum requirements for essential documents at site before IMP can be sent oval D:CTA, EthicsCommittee Approval and signed protocol 正确答案是C,错误率最高的是D选项 Notes: Section 5.14.2 of...
中科院心理咨询证书报考入口_知乎
15 因此 中科院心理所心理咨询证书 暂不接受个人报考,需在 授权机构 备案学习后由机构代报,报考链接在下方
ICH-GCP学习笔记(小白专用)_知乎
14 写在前面一开始学GCP的时候,我感觉很混乱没有框架,每一条都很细致,但是对于小白来说,很难GET到重点.稀里糊涂地看完了GCP和ICH GCP,觉得...