臨床英語(yǔ)術(shù)語(yǔ)縮寫表

臨床研究常用術(shù)語(yǔ)縮寫表編號(hào)術(shù)語(yǔ)縮寫英文全稱/中文全稱ADRAdversedrugreaction/不良反應(yīng)[AEAdverseEvent/不良事件ASVAccompaniedSiteVisit/陪同訪視BD業(yè)務(wù)拓展BusinessDevelopmentBS生物統(tǒng)計(jì)BiostatisticsCCFCentralClinicalFile申辦方臨床研究文件夾CDControlledDocuments/控制文件CDAConfidentialityDisclosureAgreement/保密協(xié)議CDCCenterforDiseaseControl/疾病控制中心CSDsClinicalStudyDocuments臨床研究文件CECCentralEthicsCommittee/中心倫理委員會(huì)?Co-ICoordinatingInvestigator負(fù)責(zé)協(xié)調(diào)不同中心參加多中心臨床試驗(yàn)研究者的研究者COFChangeOrderForm/工作氾圍變更申請(qǐng)表CIFCentralInvestigator'sFile申辦者研究者文件夾（中心研究者文件夾）CMClinicalMonitoring/Operations/臨床監(jiān)杳/運(yùn)營(yíng)CMAClinicalMonitoringAssociate/臨床研究監(jiān)查助理CRCompleteResponse痊愈CRAClinicalResearchAssociate(equivalenttoClinicalStudyMonitor)臨床監(jiān)查員CRCClinicalResearchCoordinator/臨床研究協(xié)調(diào)員CRFCaseReportFormorCaseRecordForm/病例扌報(bào)告表CRO/ContractResearchOrganization/合同研究組織CSDsClinicalStudyDocuments/臨床研究文件CSRClinicalStudyReport/臨床研究報(bào)告CTAClinicalTrialAssistant(equivalenttoClinicalResearchAssistant)臨床研究助理CTAClinicalTrialAgreement/臨床試驗(yàn)協(xié)議CTAClinicalTrialApplication/臨床試驗(yàn)申請(qǐng)CTSClinicalTrialSupplies/臨床試驗(yàn)用品>CTXClinicalTrialExemption/臨床試驗(yàn)免責(zé)

編號(hào)術(shù)語(yǔ)縮寫英文全稱/中文全稱CVCurriculumVitae/履歷DCFDataClarificationForm/數(shù)據(jù)澄清表DCRDataClarificationReport(seeDCF)/數(shù)據(jù)澄清報(bào)告DCRFDataClarificationandResolutionForm(seeDCF)/數(shù)據(jù)澄清和解決表DMDataManagement/數(shù)據(jù)管理DMPDataManagementPlan/數(shù)據(jù)管理計(jì)劃書DQFDataQueryForm/數(shù)據(jù)疑問表DSDataSource/數(shù)據(jù)源ECEthicsCommittee/倫理委員會(huì)}eCRFElectronicCaseReportForm/電子病歷扌艮告表EDCElectronicDataCapture/電子數(shù)據(jù)米集EOSEndofStudy/研究結(jié)束?EUEuropeanUnion/歐盟FASFullAnalysisSet/全分析集FDAFoodandDrugAdministration/美國(guó)食品藥品管理局FMApprovedStandardForm/批準(zhǔn)的標(biāo)準(zhǔn)表格GCPGoodClinicalPractice/臨床試驗(yàn)質(zhì)量管理規(guī)范GLPGoodLaboratoryPractice/實(shí)驗(yàn)室質(zhì)量管理規(guī)范GMPGoodManufacturingPractice/藥品生產(chǎn)質(zhì)量管理規(guī)范【GRPGoodResearchPractice/科學(xué)研發(fā)質(zhì)量管理規(guī)范GSPGoodStatisticalPractice/統(tǒng)計(jì)質(zhì)量管理規(guī)范HCOHeadofClinicalOperations臨床運(yùn)營(yíng)總監(jiān)IBInvestigator'sBrochure/研究者手冊(cè)ICInformedConsent/知情同意ICFInformedConsentForm(alsoseeIC)/矢知情同意書ICHInternationalConferenceonHarmonization/國(guó)際協(xié)調(diào)會(huì)議ICH-GCPInternationalConferenceonHarmonisationTripartiteGuidelineonGoodClinicalPractice國(guó)際協(xié)調(diào)會(huì)議藥品臨床試驗(yàn)質(zhì)量管理規(guī)范指南IDBInvestigationalDrugBrochure/試驗(yàn)藥物手冊(cè)IEC《IndependentEthicCommittee/獨(dú)立倫理委員會(huì)INDInvestigationalNewDrug(USFDA)/研究用新藥

編號(hào)術(shù)語(yǔ)縮寫英文全稱/中文全稱IPInvestigationalProduct/研究用產(chǎn)品IRAEsImmediatelyReportableAdverseEvents/立即上報(bào)的不良事件!IRBInstitutionalReviewBoard./機(jī)構(gòu)審查委員會(huì)ITTIntentiontotreat/意向性治療ISAInvestigatorStudyAgreement/研究者合同ISFInvestigationalSiteFile研究者文件夾LMLineManager/直線經(jīng)理LOILetterofIntent/意向書MOH￥MinistryofHealth/衛(wèi)生部MSAMasterServicesAgreement/主服務(wù)協(xié)議MTDMaximumToleratedDose/取大耐受劑量MWMedicalWriting/醫(yī)學(xué)寫作1NANotAvailable/不可用NCENewChemicalEntity/新化學(xué)實(shí)體NCSNotClinicallySignificant/無(wú)臨床意義NDNotDone/未做NDANewDrugApplication./新藥上市申請(qǐng)ODOtherDocuments/其他文件OP{OperatingProcedure/操作規(guī)程OOSOutOfScope/超工作范圍OSOverallSurvival/總體生存期OTLOperationalTeamLead/運(yùn)營(yíng)團(tuán)隊(duì)負(fù)責(zé)人?PDProtocolDeviation/方案偏離PIPrincipleInvestigator/主要研究者PINPersonalIdentificationNumber/個(gè)人確認(rèn)密碼PKPharmacokinetics/藥物代謝動(dòng)力學(xué)PMProjectManager/項(xiàng)目經(jīng)理PMFProjectManagermentFile/項(xiàng)目官理文件夾PMIPeriodicMaintenanceInspection/定期維護(hù)檢查PMSPost-MarketingSurveillance/上市后藥物檢測(cè)PPProjectPlan/項(xiàng)目計(jì)劃PPPerProtocol/付合方案集PRPatientRecruitment/患者招募

編號(hào)術(shù)語(yǔ)縮寫英文全稱/中文全稱QAQualityAssurance/質(zhì)量管理QCQualityControl/質(zhì)量控制RARegulatoryAuthorities/監(jiān)督管理部門RMRemoteMonitoring/遠(yuǎn)程監(jiān)查On-SiteMonitoring/現(xiàn)場(chǎng)監(jiān)查=On-TargetMonitoring/目標(biāo)化監(jiān)杳SAESeriousAdverseEvent/嚴(yán)重不良事件SCStudyCoordinator/研究協(xié)調(diào)員SCVSiteClose-outVisit/中心關(guān)閉訪視SSVSiteSelectionVisit/中心篩選訪視@SMVSiteMonitoringVisit/中心監(jiān)杳訪視SVRSiteVisitReport/中心訪視報(bào)告SDSourceData/源數(shù)據(jù)SDVSourceDataVerification/原始數(shù)據(jù)核查SFDAStateFoodandDrugAdministration/國(guó)家食品藥品監(jiān)督管理局SICSubjectIdentificationCode/受試者識(shí)別代碼SIFSiteInformationForm/中心信息表SIVSiteInitiationVisit/中心啟動(dòng)訪視SOPStandardOperatingProcedure/標(biāo)準(zhǔn)操作規(guī)程SOWScopeofWork/工作范圍Sub-ISubinvestigator次要研究者SUSARSuspectedUnexpectedSeriousAdverseReaction可疑的非預(yù)期的嚴(yán)重不良反應(yīng)TPTemplate/模版$TMFTrialMasterFile/試驗(yàn)主文檔UADRUnexpectedAdverseDrugReaction/非預(yù)期藥物不良反應(yīng)UADEUnanticipatedadversedrugeffect/非預(yù)期的不良反應(yīng)UAEUnexpectedadverseevent/非預(yù)期的不良事件WIWorkInstruction/工作指南SOP類型縮寫表OP操作規(guī)程OperatingProceduresWI工作指南WorkInstructionsTP模板TemplateFM批準(zhǔn)的標(biāo)準(zhǔn)表格ApprovedStandardFormsODOD其他文件OtherDocuments業(yè)務(wù)部門縮寫表/FunctionalAreaAbbreviationTable:BS生物統(tǒng)計(jì)BiostatisticsBD業(yè)務(wù)拓展BusinessDevelopmentCM臨床監(jiān)查/運(yùn)營(yíng)ClinicalMonitoring/OperationDataManagementInformationTechnology醫(yī)學(xué)科學(xué)服務(wù)DataManagementInformationTechnology醫(yī)學(xué)科學(xué)服務(wù)MedicalScienceService項(xiàng)目管理ProjectManagement質(zhì)量保證QualityAssurance記錄管理RecordsManagementAffairsIT信息技術(shù)MSPMQARMRA注冊(cè)事務(wù)RegulatoryManagementSMSOP管理sopManagementST研究中心官理服務(wù)SiteManagementServiceTR培訓(xùn)Trai