QualityManagementinClinicalTrialResearchAPracticalGuidetoACRCtitle,partoftheTaylor&Francisimprint,amemberoftheTaylor&FrancisGroup,theacademicdivisionofT&FInformaplc.QualityManagementinClinicalTrialResearchAPracticalGuidetoGrahamD.OggBocaRatonLondonNewYorkPublishedin2006byCRCPressTaylor&FrancisGroup6000BrokenSoundParkwayNW,Suite300BocaRaton,FL33487-2742©2006byTaylor&FrancisGroup,LLCCRCPressisanimprintofTaylor&FrancisGroupNoclaimtooriginalU.S.GovernmentworksPrintedintheUnitedStatesofAmericaonacid-freepaper10987654321InternationalStandardBookNumber-10:0-8493-9722-7(Hardcover)InternationalStandardBookNumber-13:978-0-8493-9722-6(Hardcover)Thisbookcontainsinformationobtainedfromauthenticandhighlyregardedsources.Reprintedmaterialisquotedwithpermission,andsourcesareindicated.Awidevarietyofreferencesarelisted.Reasonableeffortshavebeenmadetopublishreliabledataandinformation,buttheauthorandthepublishercannotassumeresponsibilityforthevalidityofallmaterialsorfortheconsequencesoftheiruse.Nopartofthisbookmaybereprinted,reproduced,transmitted,orutilizedinanyformbyanyelectronic,mechanical,orothermeans,nowknownorhereafterinvented,includingphotocopying,microfilming,andrecording,orinanyinformationstorageorretrievalsystem,withoutwrittenpermissionfromthepublishers.Forpermissiontophotocopyorusematerialelectronicallyfromthiswork,pleaseaccesswww.copyright.com(http://www.copyright.com/)orcontacttheCopyrightClearanceCenter,Inc.(CCC)222RosewoodDrive,Danvers,MA01923,978-750-8400.CCCisanot-for-profitorganizationthatprovideslicensesandregistrationforavarietyofusers.FororganizationsthathavebeengrantedaphotocopylicensebytheCCC,aseparatesystemofpaymenthasbeenarranged.TrademarkNotice:Productorcorporatenamesmaybetrademarksorregisteredtrademarks,andareusedonlyforidentificationandexplanationwithoutintenttoinfringe.LibraryofCongressCataloging-in-PublicationDataCatalogrecordisavailablefromtheLibraryofCongressVisittheTaylor&FrancisWebsiteathttp://www.taylorandfrancis.comandtheCRCPressWebsiteathttp://ww...