MHRA数据完整性指南-2018(中英文).pdf

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1、MHRAGXPDataIntegrityGuidanceandDefinitions;Revision1:March2018Medicines&HealthcareproductsRegulatoryAgency(MHRA)‘GXP’DataIntegrityGuidanceandDefinitionsGXP数据完整性指南和定义March2018MHRAGXPDataIntegrityGuidanceandDefinitions;Revision1:March2018目录1.Background

2、背景....................................................................................................................32.Introduction概述...................................................................................................................

3、.33.Theprinciplesofdataintegrity数据完整性原则......................................................................44.Establishingdatacriticalityandinherentintegrityrisk建立数据关键性和内在完整性风险.......55.Designingsystemsandprocessestoassuredataintegrity;creatingthe‘

4、rightenvironment’.设计系统和流程确保数据完整性，创建“正确环境”............................................76.Definitionoftermsandinterpretationofrequirements术语定义和要求诠释............................86.1.Data数据..................................................................

5、...................................................86.2.Rawdata(synonymouswith‘sourcedata’whichisdefinedinICHGCP)原始数据（与ICHGCP中定义的“源数据”为同义词）........................................................................96.3.Metadata元数据.......................

6、.................................................................................106.4.DataIntegrity数据完整性...........................................................................................106.5.DataGovernance数据管理..............................

7、..........................................................106.6.DataLifecycle数据生命周期......................................................................................116.7.Recordingandcollectionofdata数据记录和采集........................................

8、..............116.8.Datatransfer/migration数据转移/迁移......................................................................126.9.DataProcessing数据处理.........................................................................................126.10.ExcludingDa