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1、ToolSummarySheetTool:SiteAssessmentQuestionnaire(Pre-visit)Purpose:Toobtaininformationforassessmentofsiteexperience,capabilities,facilities,andoverallpreparednessforsuccessfulexecutionofstudyspecificprotocolrequirements.Audience/User:CROMS,OCTOM,clinic
2、alsitePI,clinicalsitestudycoordinator,NIDCRandprogramofficialsDetails:Thisdocumentservesasaguideforthecollectionofpertinentsiteinformationintheearlystagesofstudystartup.InformationcollectedwillinformCROMS/OCTOMinmovingthesitetowardssuccessfulsiteactiva
3、tion.BestPracticeRecommendations:·ThisdocumentmaybeusedinconjunctionwithateleconferenceatwhichtheinformationiscollectedORthequestionnairemaybedistributedforcompletionpriortotheteleconference.Itisatthediscretionoftheprojectleadertodeterminethebestapproa
4、chonasitebysitebasis.·Knowninformationwillpre-filledtoassistthesiteincompletion.Additionally,questionsthatarenotrelevantwillbeeliminated(i.e.,shadedgrey)andwillnotbeasked.·Updatethetemplatetoreflectstudyspecificrequirementsensuringthatkeypointsarecaptu
5、red(e.g.,studysupplies,staffexperience,facilityrequirements,IRB).ToolRevisionHistory:VersionNumberDateSummaryofRevisionsMade:3.029NOV2011AddedToolSummarySheetandrevisedinformedconsentreferencesSiteAssessmentQuestionnairev3.02011-11-29Page20of20National
6、InstituteofDentalandCraniofacialResearchClinicalResearchOperationsandManagementSupportPre-VisitSiteAssessmentQuestionnaireCompletionInstructionsPleaseprovidetheinformationrequestedinthisquestionnaire.Ifasectionorspecificquestionisnotapplicable,marktheN
7、/AboxorwriteinN/A.Ifaquestionisshadedgrey,itisnotapplicableforyoursiteanddoesnotneedtobeanswered.DateCompleted:SitePI:SiteName:Address(es):StudyCoordinator:N/A,specifyreason:______________Back-upStudyCoordinator:N/ANIDCRProtocolNumber:N/AOtherProtocolN
8、umberUsedbythisSite:N/ASiteAssessmentQuestionnairev3.02011-11-29Page20of20I.SiteContactInformation1.PrincipalInvestigator:N/AName:OfficialAddress:DailyAddress,ifdifferentthanabove:StreetAddressforOvernightMail,ifdifferentthanabove:Phone
