临床研究中的数据管理标准CDISC及其应用前景

ChineseJournalofNewDrugs20112024240020112024“”2008ZX09312-022。[e-mail]。、。[e-mail]。··CDISC100091CDISC、、/。CDISCCDASH、LAB、ODM、SDTM、ADaM。、CDISCCDASHSDTMAdaMCDISC。R95B1003－3734201124－2400－05ApplicationsandprospectsofdatamanagementstandardsinClinicalDataInterchangeStandardsConsortiuminclinicalresearchLUFangGAORuiTANGXu-dongLIRuiXiyuanHospitalChinaAcademyofChineseMedicalSciencesBeijing100091ChinaAbstractDatamanagementstandardsinClinicalDataInterchangeStandardsConsortiumCDISChavebeenextensivelyappliedinclinicalresearch．Itservestoprioritizedatacollectiontransmissionandstoragesim-plifydatasubmissionprocedurefromappliers/researcherstomanagingdepartmentandthusimproveefficiencyofclinicalresearch．CDISCincludesclinicaldataacquisitionstandardsharmonizationCDASHLABODMstudydatatabulationmodelSDTManalysisdatasetmodelADaMandsoon．Inthispaperwedescribedthesig-nificanceofdatamanagementstandardsinmedicalresearchandCDISCmodulesofCDASHSDTMandAdaMthathavebeenapplyingwidelyatpresent．TheprospectsofdatamanagementstandardsinCDISCinclinicalre-searchwerealsodescribed．KeywordsdatamanagementstandardClinicalDataInterchangeStandardsConsortiumCDISCclinicaldataacquisitionstandardsharmonizationCDASHstudydatatabulationmodelSDTManalysisdata-setmodelADaMClinicalDataInter-changeStandardsConsortiumCDISC、、、、、。1。CDISCclini-caldataacquisitionstandardsharmonizationCDASH、LAB、ODM、studydatatabulationmodelSDTM、analysisdatasetmodelADaM。、ChineseJournalofNewDrugs20112024240120112024、/。、CDISCCDASHSDTMADaMCDISC。1、、、、、。FDACDISCSDTM。。。2CDISC2．1CDASH2CDASHCDISC200810。CDASH、、。2．1．1CDASH。CDASH、161。、、、116。1CDASHSDTMCSASHSDTM、concomitantmedicationsCMexposureEXsubstanceuseSU●●●●●●、adverseeventsAEdispositionDSmedicalhistoryMHprotocoldeviationsDVclinicaleventsCE●●●●●●●●●、、//ECGtestresultsEGinclusion/exclusioncriterionnotmetIElaboratorytestresultsLBphysicalexaminationsPEquestionnairesQSsubjectcharacteristicsSCvitalsignsVSdrugaccountabilityDAmicrobiologyspecimenMBmicrobiologysusceptibilitytestMSpharmacokineticconcentrationsPCpharmacokineticparametersPPfindingsaboutFA●●●●●●●●●●●●●●●●●●●●ChineseJournalofNewDrugs201120242402201120241CSASHSDTMdemographicsDM●●/commentsCO●●—subjectelementsSE●subjectvisitsSV●trialarmsTA●trialelementsTE●trialvisitsTV●/trialinclusion/exclusioncriteriaTI●trialsummaryTS●—supplementalqualifiersSUPPQUALrelatedrecordsRELREC●●2．1．2CDASH116。88①。②。③SDTMCDASH、SDTM、SDTM。④BRIDGNCI、FDA、HL7CDISCHL7CDISCBRIDG3．0。⑤。⑥casereportformCRFCRF。⑦CRF。⑧HR、R/CO3。2．2SDTM3SDTM。、、。CDISC20042009。FDASDTM。2．2．1、。。SDTM5①、、、。②。③。④。。SDTM5a-CAT-SCATb-ORRES-STRESC-STRESN、c-MODIFY-DECOD//-TRT-TERM-TEST-LOINCChineseJournalofNewDrugs20112024240320112024logicalobservationidentifiersnamesandcodesLOINC-TESTCDdDMAGESEXRACE、-BLFL-POS-SPEC-NAM、、e。-ORRES-OR-RESU-ORNRHI-ORNRLO、-DOSU-DOSE。⑤、。2．2．2SDTM。。“define”。define．xml7SDTM。7、、、、、。2．2．3CDASHSDTM6、1。2．3ADaM4ADaM。。“”。、、。2．3．1ADaMADaMsubject-levelanalysisdatasetAD-SLbasicdatastructureBDS。2．3．1．1ADSL。SDTM。ADSL。ADSL、、、/、、、、。、、。2．3．1．2BDS、、、、、。BDS、、、logistic、CMHχ2、、。。2．3．2ADaM2．3．2．1、、、、、ADSLBDS、、7。2．3．2．2、、、、、、/、。2．3．2．3BDS。BDSPARAMPARAMCDPARAMChineseJournalofNewDrugs20112024240420112024。2．3．2．4。、、、、、、、、、、、。3CDISC3．1CDISCCRFAE、MH、DM。CDASHCRFCRF。CRFDMCRFCRF、。。LAB30%～50%。60%～80%5。3．2CDISC。。、、。3．3CDISC。NCIFDAHL7CDISCBRIDG6。HL7CDISC。CDISCPRM、、、。、300BRIDG7。。、。CDISC。1CDISC．Mission＆PrinciplesEB/OL．2010－12－20．ht-tp//．cdisc．org/mission-and-principles．2CDISCCDASHProjectTeam．ClinicaldataacquisitionstandardsharmonizationCDASHVersion1．0．ClinicalDataInterchangeStandardsConsortiumEB/OL．2008－10－01．http//．cdisc．org/cdash/index．html．3CDISCSubmissionsDataStandardsTeam．Studydatatabulationmodelversion1．2．ClinicalDataInterchangeStandardsConsorti-umEB/OL．2008－11－12．http//．cdisc．org/sdtm．4CDISCAnalysisDataModelTeam．Analysisdatamodelversion2．1．ClinicalDataInterchangeStandardsConsortiumEB/OL．2009－12－17．http//．cdisc．org/adam．5BASSIONS．TheCDISCLabModelsavinguserstimeandmon-ey．AppliedClinicalTrialsR．WalnutCreekCATheBiotechCommunicationsGroup2005．6BECKYAJEAND．BRIDG3．0．1Comprehensivedomainanal-ysismodelEB/OL．2009－12－30．http//．cdisc．org/bridg．7TheCDISCProtocolRepresentationGroupPRG．Theprotocolrepresentationmodelversion1．0EB/OL．2009－05－04．http//．cdisc．org/protocol．/2011－05－22