临床试验机构研究者培训的标准操作规程

©1994-2010ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.:PP(4):474-47620032122032004201217(2002AA2Z341i),,,,,,,,Tel:[phone]Fax:[phone]E2mail:[e-mail],[e-mail],,,,,,,210029,,GCP,,,,,,,;;;:R33:A:100922501(2004)0420474203,,GCP,,WHO,ICH,SFDAGCP,,,[1,2]1,:(1),,;(2),,,,,,,,,,,,2,,,,,,,,,,GCP,,474©1994-2010ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.(1):,,,P,,(1):SFDA,[3],:,,,,3.2(),1.:(,,),,2.P:P,,3.:,,,4.,3.3SFDA,,,,,,,3.4,,,,,P(),,,3.5,GCP,;4,,,,5,5.1,,,,,5.2(),;;()5.3,,,,,,5742004Apr;9(4)©1994-2010ChinaAcademicJournalElectronicPublishingHouse.Allrightsreserved.:,,,,1GoodClinicalDataManagementPracticesCommittee:GoodClinicalDataManagementPractices(Version2,January2002)[S].2SpecialProgramsforResearchandTraininginTropicalDiseases(TDR):HandbookQualityStandardsinBasicBiomedicalRe2search[S].20023,,,,,.[J].,2004;9(6)()ProceduresforinvestigatorstrainingininstitutionsforclinicaltrialsWANGYi2Bing,XIONGNing2Ning,BOQing2Yan,JIANGMeng,LIUFang,ZHOUJian2Dong,FUWei2MinNationalBaseforDrugClinicalTrial,AffiliatedHospitalofNanjingUniversityofTraditionalChineseMedicine,Nanjing210029,Jiangsu,ChinaABSTRACTQualifiedinvestigatorsplayakeyroleinguaranteeingthequalityofclinicaltrials.Receivingtrain2ingprogramsarrangedbyclinicaltrialinstitutionforeachprojectisaprerequisitetoqualifyinvestigators.TheSOPfortrainingonthebasisofGCPaswellaspracticalexpe2riencesinthispaperincludeestablishingtrainingplan,trainingprogramsforeachposition,pre2trailtrainingpro2grams,principlesandtechniquesintraining,evaluatingtrainingprograms,reviewingqualificationsoftrainers,andmaintainingtrainingdocumentationandarchives.KEYWORDSinstitutionofclinicaltrial;investigator,training;standardoperatingprocedures674ChinJClinPharmacolTher2004Apr;9(4)