臨床英語(yǔ)術(shù)語(yǔ)縮寫(xiě)表

1、臨床研究常用術(shù)語(yǔ)縮寫(xiě)表編P術(shù)語(yǔ)縮寫(xiě)英文全稱(chēng)/中文全稱(chēng)ADRAdversedrugreaction/不良反應(yīng)AEAdverseEvent/不良事件ASVAccompaniedSiteVisit/陪同訪(fǎng)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CSDsClinicalStudyDocume

2、nts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CIFCentralInvestigatorsFile申辦者研允者文件夾（中心研先者文件夾）CMClinicalMonitoring/Operations/臨床監(jiān)查/返宮CMAClinicalMonitoringAssociate/臨床研究監(jiān)查助理CRCompleteResponse痊愈CRAClinicalResearchAssociate(equiv

3、alenttoClinicalStudyMonitor)臨床監(jiān)查員CRCClinicalResearchCoordinator/臨床研究協(xié)調(diào)員CRFCaseReportFormorCaseRecordForm/病例報(bào)CROContractResearchOrganization/合1司研究組織CSDsClinicalStudyDocuments/臨床研究文件CSRClinicalStudyReport/臨床研究報(bào)告CTAClinicalTrialAssistant(equivalenttoClinicalResearchAssistant)臨床研究助理CTAClinicalTrialAgree

4、ment/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)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)澄清和解決表編P術(shù)語(yǔ)縮寫(xiě)英文全稱(chēng)/中文全稱(chēng)DMDataManagement/數(shù)據(jù)管理DMPDataMan

5、agementPlan/數(shù)據(jù)管理計(jì)劃書(shū)DQFDataQueryForm/數(shù)據(jù)疑問(wèn)表DSDataSource/數(shù)據(jù)源ECEthicsCommittee/倫理委員會(huì)eCRFElectronicCaseReportForm/電子病歷報(bào)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

6、試驗(yàn)質(zhì)量管理規(guī)范GLPGoodLaboratoryPractice/頭驗(yàn)至質(zhì)量管理規(guī)也GMPGoodManufacturingPractice/藥品生產(chǎn)質(zhì)量管理規(guī)也GRPGoodResearchPractice/科學(xué)研發(fā)質(zhì)量管理規(guī)也GSPGoodStatisticalPractice/統(tǒng)計(jì)質(zhì)量管理規(guī)也HCOHeadofClinicalOperations臨床返宮忌監(jiān)IBInvestigator'sBrochure/研允者手冊(cè)ICInformedConsent/知情同意ICFInformedConsentForm(alsoseeIC)/知情同息書(shū)ICHInternationalConfe

7、renceonHarmonization/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IECIndependentEthicCommittee/獨(dú)立倫理委員會(huì)INDInvestigationalNewDrug(USFDA)/研先用新藥IPInvestigationalProduct/研究用產(chǎn)品IRAEsImmediatelyReportableAd

8、verseEvents/立即上報(bào)的不良事件IRBInstitutionalReviewBoard./機(jī)構(gòu)審查委員會(huì)ITTIntentiontotreat/后向性治療ISAInvestigatorStudyAgreement/研究者合同ISFInvestigationalSiteFile研允者文件夾LMLineManager/直線(xiàn)經(jīng)理LOILetterofIntent/息向書(shū)MOHMinistryofHealth/衛(wèi)生部MSAMasterServicesAgreement/主服務(wù)協(xié)議MTDMaximumToleratedDose/最大耐受劑量MWMedicalWriting/醫(yī)學(xué)寫(xiě)作NANotA

9、vailable/、可用NCENewChemicalEntity/新化學(xué)實(shí)體編P術(shù)語(yǔ)縮寫(xiě)英文全稱(chēng)/中文全稱(chēng)NCSNotClinicallySignificant/無(wú)臨床意義NDNotDone/未做NDANewDrugApplication./新藥上市申請(qǐng)ODOtherDocuments/其他文件OPOperatingProcedure/操作規(guī)程O(píng)OSOutOfScope/超工作范圍OSOverallSurvival/總體生存期OTLOperationalTeamLead/運(yùn)呂團(tuán)隊(duì)人PDProtocolDeviation/方案偏離PIPrincipleInvestigator/主要研究者PINP

10、ersonalIdentificationNumber/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)目管理文件夾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/符合方案集PRPatientRecruitment/MW招募QAQualityAssurance/質(zhì)量管理QCQualityControl/質(zhì)量控制RARe

11、gulatoryAuthorities/監(jiān)督管理部門(mén)RMRemoteMonitoring/遠(yuǎn)程監(jiān)查On-SiteMonitoring/現(xiàn)場(chǎng)監(jiān)查=On-TargetMonitoring/目標(biāo)化監(jiān)查SAESeriousAdverseEvent/嚴(yán)重不良事件SCStudyCoordinator/研究協(xié)調(diào)員SCVSiteClose-outVisit/中心關(guān)閉訪(fǎng)視SSVSiteSelectionVisit/中心篩選訪(fǎng)視SMVSiteMonitoringVisit/中心監(jiān)查訪(fǎng)視SVRSiteVisitReport/中心訪(fǎng)視報(bào)告SDSourceData/源數(shù)據(jù)SDVSourceDataVerificatio

12、n/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(fǎng)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/、良反應(yīng)TPTemplate/模版

13、編p術(shù)語(yǔ)縮寫(xiě)英文全稱(chēng)/中文全稱(chēng)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(lèi)型縮寫(xiě)表OP操作規(guī)程O(píng)peratingProceduresWI工作指南WorkInstructionsTP模板TemplateFM批準(zhǔn)的標(biāo)準(zhǔn)表格ApprovedStandardFormsOD其他文件OtherDocuments業(yè)務(wù)

14、部門(mén)縮寫(xiě)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/OperationDM數(shù)據(jù)管理DataManagementIT信息技術(shù)InformationTechnologyMS醫(yī)學(xué)科學(xué)服務(wù)MedicalScienceServicePM項(xiàng)目管理ProjectManagementQA質(zhì)量保證QualityAssuranceRM記錄管理RecordsManagementRA注冊(cè)事務(wù)RegulatoryAffairsSMSOPH理SOPManagementST研究中心管理服務(wù)SiteManagementServiceTR培訓(xùn)Training試驗(yàn)主