1 原文(Original) 1.13 Clinical Trial/Study Report A written deion of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical deion, presentations, and analyses are fully integrated into a single report (see the ICH Gu...
1 原文(Original) 1.5 Approval (in relation to Institutional Review Boards) The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and ...
让我们一起从头开始学习ICH GCP原文(15)【申办方-递交监管当局、机构或伦理审批确认、IP相关】 梨米TALK 业余时间不务正业的临床试验稽查员3 人赞同了该文章 5.10 Notification/Submission to Regulatory Authority(ies) Before initiating the clinical trial(s), the sponsor (or the sponsor and the investig...
2.1 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicableregulatoryrequirement(s). 针对伦理原则——临床试验应该遵循以赫尔辛基宣言、GCP、监管当局要求为基础的伦理原则。 2.2 ...
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编者按:如需快速直达ICH-GCP R2中文版链接,请直接滑动屏幕至文末”阅读原文“ 公元1996年,ICH-GCP正式发布R1版,彼时之中国,了解GCP的人仅限于当时中国卫生部培养的数百名医学专家,规范的临床试验法规与体系还在起草中。1998年3月卫生部而发布了中国第一部GCP(试行),同年5月实施;1998年国务院机构改革成立了国家药...
原文(Original) 5.12.2 The sponsor should update the Investigator's Brochure as significant new information becomes available (see 7. Investigator's Brochure). 5.13 Manufacturing, Packaging, Labelling, and Coding Investigational Product(s) 5.13.1 The sponsor should ensure that the investigational product...
编者按:如需快速直达ICH-GCP R2中文版链接,请直接滑动屏幕至文末”阅读原文“ 公元1996年,ICH-GCP正式发布R1版,彼时之中国,了解GCP的人仅限于当时中国卫生部培养的数百名医学专家,规范的临床试验法规与体系还在起草中。1998年3月卫生部而发布了中国第一部GCP(试行),同年5月实施;1998年国务院机构改革成立了国家药...
ICH—GCP 课程中文翻译+QUIZ参考 (完结于 22.12.20)以下文字的原文链接见上*(链接中有目录可以方便跳…