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临床试验没有事儿——GCP纵横杂谈
$42.79
本书内容主要来自临床试验领域资深从业人员在多年耕耘与实践
中的工作体会、心得总结和思考,积累成文,汇集成册,期望与更
多同行分享交流,也期望对业内同行有一定参考价值。全书涉及临
床试验多个方面和不同视角与维度,有涉及法规的,也有操作层面
的;有自己的实践体会,也有海外见闻。为方便阅读,全书共分为6
篇,分别为机构管理篇、试验技术操作篇、试验质量篇、伦理审查
与受试者保护篇、综合篇和海外攻玉篇。
目 录
篇 机构管理篇1
我国药物临床试验机构发展的现状与问题探讨 2
试验合同签署关键点之一:合同主体问题 6
试验合同签署关键点之二:国外申办者授权委托书的法律效力 8
制定临床试验合同中的主要条款分析11
专业组GCP 秘书,还要继续游离于试验项目之外吗?17
探讨医院引入临床研究协调员及第三方稽查员19
再议CRO 中心实验室的合规性24
临床试验信息化建设,各个系统应贯通26
药物临床试验医院信息系统免费医嘱系统的应用29
转变试验机构管理模式,为临床试验保驾护航33
取消机构认证带来的机遇与挑战35
关于临床试验机构备案“参加过3 个以上药物临床试验”的问题思考38
勿忘初心:机构备案的好事需要办实了42
第二篇 试验技术操作篇49
《国际多中心临床试验指南意见稿》分析与建议50
当前国内临床试验中一些技术难点、疑点和建议(一)52
当前国内临床试验中一些技术难点、疑点和建议(二)56
如何开好临床试验中心启动会58
PI,请像对待病历一样对待临床试验记录61
如何处理研究中的违背事件63
医疗器械试验过程中的一些问题及建议65
中心化的实验室检查是否必要,是否一定有利于临床试验67
解惑漏记实验室检查结果异常69
ICFProcess(知情同意过程的记录)72
第三篇 试验质量篇93
第四篇 伦理审查与受试者保护篇
第五篇 综合篇
第六篇 海外攻玉篇
后 记
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