臨床英語術(shù)語縮寫表.doc

學(xué)習(xí)資料收集于網(wǎng)絡(luò)，僅供參考臨床研究常用術(shù)語縮寫表編號(hào)術(shù)語縮寫英文全稱/中文全稱ADRAdverse drug reaction/不良反應(yīng)AEAdverse Event/不良事件ASVAccompanied Site Visit/陪同訪視BD業(yè)務(wù)拓展Business DevelopmentBS生物統(tǒng)計(jì) BiostatisticsCCFCentral Clinical File申辦方臨床研究文件夾CDControlled Documents/控制文件CDAConfidentiality Disclosure Agreement/保密協(xié)議CDCCenter for Disease Control/疾病控制中心CSDsClinical Study Documents臨床研究文件CECCentral Ethics Committee/中心倫理委員會(huì)Co-ICoordinating Investigator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COFChange Order Form/工作范圍變更申請(qǐng)表CIFCentral Investigators File申辦者研究者文件夾（中心研究者文件夾）CMClinical Monitoring / Operations/臨床監(jiān)查/運(yùn)營(yíng)CMAClinical Monitoring Associate/臨床研究監(jiān)查助理CRComplete Response痊愈CRAClinical Research Associate (equivalent to Clinical Study Monitor)臨床監(jiān)查員CRCClinical Research Coordinator/臨床研究協(xié)調(diào)員CRFCase Report Form or Case Record Form/病例報(bào)告表CROContract Research Organization/合同研究組織CSDsClinical Study Documents/臨床研究文件CSRClinical Study Report/臨床研究報(bào)告CTAClinical Trial Assistant (equivalent to Clinical Research Assistant)臨床研究助理CTAClinical Trial Agreement/臨床試驗(yàn)協(xié)議CTAClinical Trial Application/臨床試驗(yàn)申請(qǐng)CTSClinical Trial Supplies/臨床試驗(yàn)用品CTXClinical Trial Exemption/臨床試驗(yàn)免責(zé)CVCurriculum Vitae/履歷DCFData Clarification Form /數(shù)據(jù)澄清表DCRData Clarification Report (see DCF)/數(shù)據(jù)澄清報(bào)告DCRFData Clarification and Resolution Form (see DCF)/數(shù)據(jù)澄清和解決表DMData Management/數(shù)據(jù)管理DMPData Management Plan/數(shù)據(jù)管理計(jì)劃書DQFData Query Form/數(shù)據(jù)疑問表DSData Source/數(shù)據(jù)源ECEthics Committee /倫理委員會(huì)eCRFElectronic Case Report Form/電子病歷報(bào)告表EDCElectronic Data Capture/電子數(shù)據(jù)采集EOSEnd of Study/研究結(jié)束EUEuropean Union/歐盟FASFull Analysis Set/全分析集FDAFood and Drug Administration/美國(guó)食品藥品管理局FMApproved Standard Form/批準(zhǔn)的標(biāo)準(zhǔn)表格GCPGood Clinical Practice/臨床試驗(yàn)質(zhì)量管理規(guī)范GLPGood Laboratory Practice /實(shí)驗(yàn)室質(zhì)量管理規(guī)范GMPGood Manufacturing Practice/藥品生產(chǎn)質(zhì)量管理規(guī)范GRPGood Research Practice/科學(xué)研發(fā)質(zhì)量管理規(guī)范GSPGood Statistical Practice/統(tǒng)計(jì)質(zhì)量管理規(guī)范HCOHead of Clinical Operations臨床運(yùn)營(yíng)總監(jiān)IBInvestigators Brochure/研究者手冊(cè)ICInformed Consent/ 知情同意ICFInformed Consent Form (also see IC)/知情同意書ICHInternational Conference on Harmonization/國(guó)際協(xié)調(diào)會(huì)議ICH-GCPInternational Conference on Harmonisation Tripartite Guideline on Good Clinical Practice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IDBInvestigational Drug Brochure /試驗(yàn)藥物手冊(cè)IECIndependent Ethic Committee/獨(dú)立倫理委員會(huì)INDInvestigational New Drug (US FDA)/研究用新藥IPInvestigational Product/研究用產(chǎn)品IRAEsImmediately Reportable Adverse Events/立即上報(bào)的不良事件IRBInstitutional Review Board. /機(jī)構(gòu)審查委員會(huì)ITTIntention to treat/意向性治療ISAInvestigator Study Agreement/研究者合同ISFInvestigational Site File 研究者文件夾LMLine Manager/直線經(jīng)理LOILetter of Intent/意向書MOHMinistry of Health/衛(wèi)生部MSAMaster Services Agreement/主服務(wù)協(xié)議MTDMaximum Tolerated Dose/最大耐受劑量MWMedical Writing/醫(yī)學(xué)寫作NANot Available/不可用NCENew Chemical Entity/新化學(xué)實(shí)體NCSNot Clinically Significant/無臨床意義NDNot Done/未做NDANew Drug Application./新藥上市申請(qǐng)ODOther Documents/其他文件OPOperating Procedure/操作規(guī)程OOSOut Of Scope/超工作范圍OSOverall Survival/總體生存期OTLOperational Team Lead/運(yùn)營(yíng)團(tuán)隊(duì)負(fù)責(zé)人PDProtocol Deviation/方案偏離PIPrinciple Investigator /主要研究者 PINPersonal Identification Number/個(gè)人確認(rèn)密碼PKPharmacokinetics/藥物代謝動(dòng)力學(xué)PMProject Manager/項(xiàng)目經(jīng)理PMFProject Managerment File/項(xiàng)目管理文件夾PMIPeriodic Maintenance Inspection/定期維護(hù)檢查PMSPost-Marketing Surveillance/上市后藥物檢測(cè)PPProject Plan/項(xiàng)目計(jì)劃PPPer Protocol/符合方案集PRPatient Recruitment/患者招募QAQuality Assurance/質(zhì)量管理QCQuality Control/質(zhì)量控制RARegulatory Authorities/監(jiān)督管理部門RMRemote Monitoring/遠(yuǎn)程監(jiān)查On-Site Monitoring/現(xiàn)場(chǎng)監(jiān)查=On-Target Monitoring/目標(biāo)化監(jiān)查SAESerious Adverse Event /嚴(yán)重不良事件SCStudy Coordinator/研究協(xié)調(diào)員SCVSite Close-out Visit/中心關(guān)閉訪視SSVSite Selection Visit/中心篩選訪視SMVSite Monitoring Visit/中心監(jiān)查訪視SVRSite Visit Report/中心訪視報(bào)告SDSource Data/源數(shù)據(jù)SDVSource Data Verification/原始數(shù)據(jù)核查SFDAState Food and Drug Administration/國(guó)家食品藥品監(jiān)督管理局SICSubject Identification Code/受試者識(shí)別代碼SIFSite Information Form/中心信息表SIVSite Initiation Visit/中心啟動(dòng)訪視SOPStandard Operating Procedure/標(biāo)準(zhǔn)操作規(guī)程SOWScope of Work/工作范圍Sub-ISubinvestigator次要研究者SUSARSuspected Unexpected Serious Adverse Reaction可疑的非預(yù)期的嚴(yán)重不良反應(yīng)TPTemplate/模版TMFTrial Master File/試驗(yàn)主文檔UADRUnexpected Adverse Drug Reaction/非預(yù)期藥物不良反應(yīng)UADEUnanticipated adverse drug effect/非預(yù)期的不良反應(yīng)UAEUnexpected adverse event/非預(yù)期的不良事件WIWork Instruction/工作指南SOP 類型縮寫表OP 操作規(guī)程 Operating ProceduresWI 工作指南 Work InstructionsTP 模板 TemplateFM 批準(zhǔn)的標(biāo)準(zhǔn)表格 Approved Standard FormsOD 其他文件 Other Documents業(yè)務(wù)部門縮寫表/ Functional Area Abbreviation Table:BS 生物統(tǒng)計(jì) BiostatisticsBD 業(yè)務(wù)拓展Business DevelopmentCM 臨床監(jiān)查/運(yùn)營(yíng)Clinical Monitoring/OperationDM 數(shù)據(jù)管理 Data ManagementIT 信息技術(shù) Information TechnologyMS 醫(yī)學(xué)科學(xué)服務(wù)Medical Science ServicePM 項(xiàng)目管理 Project ManagementQA 質(zhì)量保證 Quality AssuranceRM 記錄管理 Records ManagementRA 注冊(cè)事務(wù)Regulatory AffairsSM SOP 管理SOP ManagementST 研究中心管理服務(wù)Site Management ServiceTR 培訓(xùn) Training試驗(yàn)主文檔：（TMF） Trial Mas