進階gcp培訓研究中心選擇02nov pages

Thismaterialisnotintendedtoprovidespecificorlegaladvice.Readersshouldconsulttheir ’sSOPs,clinical,QA,regulatorydepartments,andlegalcounselforguidancewhenapplyingGCPstandardsinclinicalresearch.22選擇的流程及對應的ICHGCP要求， 描 時1天 快速回顧臨床試驗相 ，包括ICHGCP,中國GCP，藥品 冊管理辦法，藥物臨床試 工作指導原則 該部分重點講 啟動的準備、執(zhí)行和匯報，并聯(lián)系相 該部分重點講 啟動的準備、執(zhí)行和匯報，并聯(lián)系相 該部分主要講 常規(guī)監(jiān)查的準備、執(zhí)行和匯報，并通 該部分主要講 常規(guī)監(jiān)查的準備、執(zhí)行和匯報，并通 WhySiteSelection_InvestigatorThesponsorisresponsibleforselectingtheinvestigator(s)/institution(s).Eachinvestigatorshouldbequalifiedbytrainingandexperienceandshouldhaveadequateresources(see4.1,4.2)toproperlyconductthetrialforwhichtheinvestigatorisselected.Iforganizationofacoordinatingcommitteeand/orselectionofcoordinatinginvestigator(s)aretobeutilizedinmulticentretrials,theirorganizationand/orselectionarethesponsor'sresponsibility.WhySiteSelection_5.14.3Thesponsorshouldensurethatwrittenproceduresincludeinstructionsthattheinvestigator/institutionshouldfollowforthehandlingandstorageofinvestigationalproduct(s)forthetrialandationthereof.Theproceduresshouldaddressadequateandsafereceipt,handling,storage,dispensing,retrievalofunusedproductfromsubjects,andreturnofunusedinvestigationalproduct(s)tothesponsor(oralternativedispositionifauthorizedbythesponsorandincompliancewiththeapplicableregulatoryrequirement(s)).WhySiteSelection_5.11.1ThesponsorshouldobtainfromtheThenameandaddressoftheinvestigator‘s/institution’sAstatementobtainedfromtheIRB/IECthatitisorganizedandoperatesaccordingtoGCPandtheapplicablelawsandregulations.edIRB/IECapproval/favourableopinionand,ifrequestedbythesponsor,acurrentcopyofprotocol,writteninformedconsentform(s)andanyotherwritteninformationtobeprovidedtosubjects,subjectrecruitingprocedures, srelatedtopaymentsandcompensationavailabletothesubjects,andanyother sthattheIRB/IECmayhaverequested.WhySiteSelection_5.18.2SelectionandQualificationsofMonitorsshouldbeappointedbytheMonitorsshouldbeappropria ytrained,andshouldhavethescientificand/orclinicalknowledgeneededtomonitorthetrialadequa qualificationsshouldbe Monitorsshouldbethoroughlyfamiliarwiththeinvestigationalproduct(s),theprotocol,writteninformedconsentformandanyotherwritteninformationtobeprovidedtosubjects,thesponsor’sSOPs,GCP,andtheapplicableregulatoryrequirement(s).WhySiteSelection_Investigator‘sQualificationsandAdequateMedicalCareofTrialWhySiteAnIRB/IECshouldsafeguardtherights,safety,andwell-beingofalltrialsubjects.Composition,FunctionsandPerformitsfunctionaccordingto-TheIRB/IECshouldestablish, inwriting,andfollowits 人口統(tǒng)計學資料(適應癥 符