臨床英語術(shù)語縮寫表

1、臨床研究常用術(shù)語縮寫表臨床研究常用術(shù)語縮寫表編號編號術(shù)語縮寫術(shù)語縮寫英文全稱英文全稱中文全稱中文全稱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

2、文件CDAConfidentialityDisclosureAgreement保密協(xié)議CDCCenterfDiseaseControl疾病控制中心CSDsClinicalStudyDocuments臨床研究文件CECCentralEthicsCommittee中心倫理委員會(huì)CoICodinatingInvestigat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COFChangederFm工作范圍變更申請表CIFCentralInv

3、estigat’sFile申辦者—研究者文件夾（中心研究者文件夾）CMClinicalMonitingOperations臨床監(jiān)查運(yùn)營CMAClinicalMonitingAssociate臨床研究監(jiān)查助理CRCompleteResponse痊愈CRAClinicalResearchAssociate(equivalenttoClinicalStudyMonit)臨床監(jiān)查員CRCClinicalResearchCodinat臨床研究協(xié)調(diào)

4、員CRFCaseReptFmCaseRecdFm病例報(bào)告表CROContractResearchganization合同研究組織CSDsClinicalStudyDocuments臨床研究文件CSRClinicalStudyRept臨床研究報(bào)告CTAClinicalTrialAssistant(equivalenttoClinicalResearchAssistant)臨床研究助理CTAClinicalTrialAgreement臨床試

5、驗(yàn)協(xié)議CTAClinicalTrialApplication臨床試驗(yàn)申請CTSClinicalTrialSupplies臨床試驗(yàn)用品CTXClinicalTrialExemption臨床試驗(yàn)免責(zé)CVCurriculumVitae履歷DCFDataClarificationFm數(shù)據(jù)澄清表DCRDataClarificationRept(seeDCF)數(shù)據(jù)澄清報(bào)告DCRFDataClarificationResolutionFm(seeDC

6、F)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)劃書編號編號術(shù)語縮寫術(shù)語縮寫英文全稱英文全稱中文全稱中文全稱NDANewDrugApplication.新藥上市申請ODOtherDocuments其他文件OPOperatingProcedure操作規(guī)程OOSOutOfScope超工作范圍OSOverallSurvival總體生存期OTLOperationalTeamLead

7、運(yùn)營團(tuán)隊(duì)負(fù)責(zé)人PDProtocolDeviation方案偏離PIPrincipleInvestigat主要研究者PINPersonalIdentificationNumber個(gè)人確認(rèn)密碼PKPharmacokiics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PMSPostMarketin

8、gSurveillance上市后藥物檢測PPProjectPlan項(xiàng)目計(jì)劃PPPerProtocol符合方案集PRPatientRecruitment患者招募QAQualityAssurance質(zhì)量管理QCQualityControl質(zhì)量控制RARegulatyAuthities監(jiān)督管理部門RMRemoteMoniting遠(yuǎn)程監(jiān)查OnSiteMoniting現(xiàn)場監(jiān)查=OnTargetMoniting目標(biāo)化監(jiān)查SAESeriousAdve

9、rseEvent嚴(yán)重不良事件SCStudyCodinat研究協(xié)調(diào)員SCVSiteCloseoutVisit中心關(guān)閉訪視SSVSiteionVisit中心篩選訪視SMVSiteMonitingVisit中心監(jiān)查訪視SVRSiteVisitRept中心訪視報(bào)告SDSourceData源數(shù)據(jù)SDVSourceDataVerification原始數(shù)據(jù)核查SFDAStateFoodDrugAdministration國家食品藥品監(jiān)督管理局SICS

10、ubjectIdentificationCode受試者識別代碼SIFSiteInfmationFm中心信息表SIVSiteInitiationVisit中心啟動(dòng)訪視SOPStardOperatingProcedure標(biāo)準(zhǔn)操作規(guī)程SOWScopeofWk工作范圍SubISubinvestigat次要研究者SUSARSuspectedUnexpectedSeriousAdverseReaction可疑的非預(yù)期的嚴(yán)重不良反應(yīng)TPTemplat