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ID:34358812
大小:72.00 KB
页数:3页
时间:2019-03-05
《extramural site activation checklist:校外站点激活清单》由会员上传分享,免费在线阅读,更多相关内容在应用文档-天天文库。
1、Title:ExtramuralSiteActivationChecklistVersionNumber:1.0Date:23FEB2012Page3of3ToolSummarySheetTool:ExtramuralSiteActivationChecklistPurpose:ToclarifytheitemsrequiredpriortositeactivationforanNIDCRExtramuralstudy.Explicitlyincludedaremorethanminimalriskstudies.Au
2、dience/User:LeadInvestigatorsandstudyteammembersofNIDCRExtramuralstudies,theClinicalResearchOperationsandManagementSupportteam(CROMS),NIDCR’sOfficeofClinicalTrialsOperationsandManagement(OCTOM),andProgramOfficialsoftheNIDCRDetails:ThischecklistwillbepreparedbyCR
3、OMS,andusedbytheNIDCRProgramOfficialtodeterminewhenallrequirementshavebeenmetforsiteactivation.Whenalloftheserequirementshavebeenmet,CROMSwillsendthecompletedchecklisttotheOCTOMDirectorordesigneeforsignature.TheOCTOMrepresentativewillthenforwardthechecklisttothe
4、appropriateNIDCRProgramOfficialforsignature.Uponapproval,theNIDCRProgramOfficialwillsendaSiteActivationlettertothesitePIandwillprovideacopytoCROMSforthestudyfile.BestPracticeRecommendations:·Thischecklistshouldbereviewedwiththesiteinvestigatortoensureunderstandi
5、ngofitemsrequiredpriortositeactivationapproval.·ThesitemaynotbeginenrollmentuntilthesiteactivationletterfromtheNIDCRProgramOfficialisreceivedbythesite.·Textenclosedwith<>isaplaceholderforaspecificdetail(e.g.,);replaceasappropriate.·Itemsinblueital
6、icsandenclosedinbraces{}areinstructionaltextthatshouldbedeletedpriortouse.·RemovethisToolSummarySheetpriortouseoftheChecklist.ToolRevisionHistory:VersionNumberDateSummaryofRevisionsMade:1.023Feb2012SeparatedocumentoftheChecklistapprovedthroughtheGuidelinetoolTit
7、le:ExtramuralSiteActivationChecklistVersionNumber:1.0Date:23FEB2012Page3of3Protocol<#>EXTRAMURALSITEACTIVATIONCHECKLISTSiteName:Site#:ProtocolVersionandDate:ItemDate1.IRBApprovalReceivedforProtocol,ConsentForm,andOtherApplicableDocuments2.NIDCRSaf
8、etyCommittee(e.g.,CSOC,DSMB,DSMC)reviewcompleteorconfirmationthatnoSafetyCommitteewillberequired3.SiteEssentialDocumentFileApproved4.CaseReportFormsFinal5.DataManagem
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