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临床试验数据管理之数据记录的常见问题

2012-12-13 MedSci MedSci原创

数据管理
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做临床试验的数据管理，那肯定需要对数据记录进行核查的，虽然有程序核查来完成大部分数据库核查工作，不过毕竟机器不是万能，还是有一些东西需要经验老道的数据管理员来完成的。所以特此将数据记录检查时的常见问题进行了归纳汇总： 1、违规与不规范 2、造假与不严谨 3、未做与不完整 4、组织与个人行为造假 可以详细分为以下几类： GCP规范操作核查存在主要数据问题 1.无原始病历或原始病历中无记录（缺

做临床试验的数据管理，那肯定需要对数据记录进行核查的，虽然有程序核查来完成大部分数据库核查工作，不过毕竟机器不是万能，还是有一些东西需要经验老道的数据管理员来完成的。所以特此将数据记录检查时的常见问题进行了归纳汇总： 1、违规与不规范 2、造假与不严谨 3、未做与不完整 4、组织与个人行为造假 可以详细分为以下几类： GCP规范操作核查存在主要数据问题 1.无原始病历或原始病历中无记录（缺或不全）        2.检验结果不能溯源（检验数据、心电图、X光片…）        3.无统计计划书和统计报告或数据管理无序        4.知情同意书缺失或签署存在问题 知情同意书检查时的常见问题 1.知情同意书丢失或不完整，且无合理解释        2.未签署知情同意书就进行研究，或先纳入、后签署     &n

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#插入话题
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    2023-07-17 ms3000001527664206 来自吉林省

    #试验数据#

    0

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    2013-08-18 ms24272190615788285182

    #试验数据#

    0

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    2012-12-15 caobinglei8079

    #常见问题#

    0

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    2012-12-15 waiwai3033

    #数据管理#

    0

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临床试验数据管理之数据记录

一．数据记录的作用     记录是安全性、有效性的评价和报告依据,也是遵循GCP的证据, 只有存在记录: 1.才能证明相关行为发生过；        2.才能在发生任何问题时追根溯源；        3.才能证明试验是严格按照GCP、