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GCP稽查国际指南
2019-01-08 | 阅:  转:  |  分享 
  
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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.


本文件由JSQAGCP工作组起草Page8of82014年年年年4月月月月
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theSocietyofQualityAssurance(SQA).

ThisauthorisedtranslationhasbeenpreparedbytheChinaQAForum(CQAF)(http://www.cqaf.org/).
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