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1、SomeCharacteristicsofaGoodMonitorPamelaCharnleyNickols,CharnleyNickolsAssociatesLtdSummaryDoyouknowanyonelikethis?Strongandhealthy,patient,sociable,persuasive,knowledgeable,determined,hardworking,numerateandwelltrained,unsociable,noseyanddoggedlypersistentandpossessedofpsychicpowers(st
2、rongisalsousedasfirstwordinsentence).Ifsoyoumaywishtorecommendthatheorshebecomesamonitor.Whatisthepurposeofmonitoring?TheInternationalConferenceforHarmonisation(ICH)GoodClinicalPractice(GCP)GuidelinesstateinSection5.18.1thatthepurposesoftrialmonitoringaretoverifythat:a)Therightsandwell
3、-beingofhumansubjectsareprotected・b)Thereportedtrialdataareaccurate,complete,andverifiablefromsourcedocuments.c)Theconductofthetrialisincompliancewiththecurrentlyapprovedprotocol/amendment(s),withGCP,andwiththeapplicableregulatoryrequirement(s).Inordertoachievethesethreepurposesitiscle
4、arlyveryimportanttochosetherightpersonforthejob.Whoshouldbeamonitor?TheGCPGuidelinesstatethatmonitorsshouldbeappointedbythesponsor.ThisdoesnotruleouttheuseofmonitorsemployedbyContractResearchOrganisations(CROs)wheretheCROhasbeenappointedbythesponsorandhasbeendelegatedthetaskofappoint!n
5、gmonitors・TheGuidelinesprovidethatmonitorsshouldbeappropriatelytrained,andshouldhavethescientificand/orclinicalknowledgeneededtomonitorthetrialadequately.Amonitor'squalificationsshouldbedocumented.Wordssuchas^appropriately",uasneededMand^adequately"allowthesponsororitsagenttoselectmoni
6、torsaccordingtocriteriawhicharenotdefinedinGCPandmustbededuced?rivedbythesponsorfromtheotherrequirementswhichGCPplacesonthemonitor.Whateverthesecriteriaare,theachievementofthembythemonitorshouldbedemonstrableintheformofthemonitor'sup-to-dateandcomprehensiveCV.Intermsofknowledge,monitor
7、sareexpectedtobethoroughlyfamiliarwiththeinvestigationalproduct(s),theprotocol,writteninformedconsentformandanyotherwritteninformationtobeprovidedtosubjects,thesponsor'sSOPs,GCP,andtheapplicableregulatoryrequirement(s).Thiscanrepresentquiteachallengeandparticularlysoifthemonitorisinv
