CDE终于发布《临床试验数据管理工作技术指南》(附下载)

2012-12-13 MedSci MedSci原创

CDE终于发布《临床试验数据管理工作技术指南》,临床试验数据管理的第一本指导性文件。足足有47页之多。涵盖了临床试验数据管理的全过程。标志着临床试验数据管理一个新时代的开启。附详细通知内容(转载自国家食品药品监督管理局药品审评中心): 临床试验数据是支持药品获准上市的最重要实证。良好规范的数据管理工作是保证临床试验质量的关键。我国《药品注册管理办法》和《药物临床试验质量管理规范》等对此均有相应的原

CDE终于发布《临床试验数据管理工作技术指南》,临床试验数据管理的第一本指导性文件。足足有47页之多。涵盖了临床试验数据管理的全过程。标志着临床试验数据管理一个新时代的开启。附详细通知内容(转载自国家食品药品监督管理局药品审评中心): 临床试验数据是支持药品获准上市的最重要实证。良好规范的数据管理工作是保证临床试验质量的关键。我国《药品注册管理办法》和《药物临床试验质量管理规范》等对此均有相应的原则性要求。在技术操作层面还需要相应细化的技术指南。 为加强我国药物临床试验数据的规范管理,保证药物临床研究数据的质量,使药物的评价基于科学的实证,自2009年以来,我中心借鉴国际相关通用规范和技术 指南并结合当前临床试验数据管理现实,起草了《临床试验数据管理工作技术指南》,经专家会议反复讨论并形成终稿,希望业内同行对技术指南提出反馈意见和建 议以利于中心进一步的完善工作。 药审中心将进一步细化制定临床试验申报资料中数据质量评估和数据提交的具体技术要求,敬请各研发单位、药物临床试验机构、临床试验相关人员等密切关注。 具体附件: 临床试验数据管理工作技术指南.doc

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    2013-02-20 jyyjjyyjyy

    正好需要,很好

    0

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