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1、MANAGEMENTOFDATAINCLINICALTRIALSSecondEditionELEANORMCFADDENFrontierScience,Ltd.Kincraig,Inverness-shire,ScotlandWILEY-INTERSCIENCEAJOHNWILEY&SONS,INC.,PUBLICATIONMANAGEMENTOFDATAINCLINICALTRIALSMANAGEMENTOFDATAINCLINICALTRIALSSecondEditionELEANORMCFADDENFrontierScience,Ltd.K
2、incraig,Inverness-shire,ScotlandWILEY-INTERSCIENCEAJOHNWILEY&SONS,INC.,PUBLICATIONThisbookisprintedonacid-freepaper.Copyright©2007byJohnWiley&Sons,Inc.,Hoboken,NewJersey.Allrightsreserved.PublishedsimultaneouslyinCanada.Nopartofthispublicationmaybereproduced,storedinaretrieva
3、lsystemortransmittedinanyformorbyanymeans,electronic,mechanical,photocopying,recording,scanningorotherwise,expectaspermittedunderSections107or108ofthe1976UnitedStatesCopyrightAct,withouteitherthepriorwrittenpermissionofthePublisher,orauthorizationthroughpaymentoftheappropriat
4、eper-copyfeetotheCopyrightClearanceCenter,222RosewoodDrive,Danvers,MA01923,(978)750-8400,fax(978)750-4744.RequeststothePublisherforpermissionshouldbeaddressedtothePermissionsDepartment,JohnWiley&Sons,Inc.,605ThirdAvenue,NewYork,NY10158-0012,(212)850-6011,fax(212)850-6008,E-Ma
5、il:PERMREQ@WILEY.COM.Fororderingandcustomerservice,call1-800-CALL-WILEYWileyBicentennialLogo:RichardJ.PacificoLibraryofCongressCataloging-in-PublicationData:McFadden,Eleanor,1948–Managementofdatainclinicaltrials/EleanorMcFadden.—2nded.p.;cm.Includesbibliographicalreferencesand
6、index.ISBN978-0-470-04608-1(cloth:alk.paper)1.Clinicaltrials—Dataprocessing.I.Title.[DNLM:1.ClinicalTrials—methods.2.DatabaseManagementSystems.3.ResearchDesign.QV771M478m2008]R853.C55M392008615.5072′4—dc222007013685PrintedintheUnitedStatesofAmerica.10987654321Forallmyprofessi
7、onalcolleagues,pastandpresent.CONTENTSPrefaceixAcknowledgmentsxi1Introduction12StudyDesignandPlanning123DataDefinition,Forms,andDatabaseDesign334ComputerSystemsforDataManagementandDataEntry565PatientRegistration766LocalDataManagementSystems947CentralQualityControlofData1068Dat
8、aManagementandGoodClinicalPractice1219SoftwareToolsforTrialsManageme
