aaiokausThmirT 附附附附件件件件09 IRB/IEC的的稽稽查查 的的稽稽查查
5.0参参参参考考考考文文文文献献献献 ?21CFRPart56 ?Directive2001/20/ECoftheEuropeanParliamentandoftheCouncilof4 April2001ontheapproximationofthelaws,regulationsandadministrative provisionsoftheMemberstatesrelatingtotheimplementationofgood clinicalpracticeintheconduct ofclinicaltrialsonmedicalproductsforhumanuse ?Detailedguidanceontheapplicationformatanddocumentationtobe submittedinanapplicationforanEthicsCommitteeopinionontheclinical trialonmedicalproductsforhumanuse ?MHLWOrdinancenumber28issuedon27-Mar-1997(onlyJapanese) ?BioresearchMonitoringMetricsbyFDA http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RunningClini calTrials/UCM341516.pdf ?GuidanceforIRBs,ClinicalInvestigators,andSponsors-IRB ResponsibilitiesforReviewingtheQualificationsofInvestigators,Adequacy ofResearchSites,andtheDeterminationofWhetheranIND/IDEisNeeded- http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM3288 55.pdf
6.0推推推推荐荐荐荐阅阅阅阅读读读读 ?GCPAuditing.MethodsandExperience–EditedbytheGermanSocietyfor nd ResearchPractice(DGGF)2edition Good ?ClinicalTrialsAuditPreparation:aguideforgoodclinicalpractice(GCP) inspections.–EditedbyMihajlovic-Madzarevic,Published2010byJohn Wiley&Sons,Inc. ?2011GoodClinicalPractice:AQuestion&AnswerReferenceGuide–Edited byMarkP.Mathieu,publishedBARNETTEDUCATIONALSERVICES ?GuidanceforAuditingQualitySystemsofIndependentEthicsCommitteesin Europe–byNickyDodsworth,MaryO’Flaherty,ColinWilsher,Published 2008byThe EuropeanForumforGoodClinicalPractice.
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