臨床英語術(shù)語縮寫表

1、臨床研究常用術(shù)語縮寫表編號術(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 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CSDsClin

2、ical Study Documents臨床研究文件CECCentral Ethics Committee/中心倫理委員會Co-ICoordinating Investigator負(fù)責(zé)協(xié)調(diào)不同中心參加多中心臨床試驗研究者的研究者COFChange Order Form/工作范圍變更申請表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/運營CMAClinical Monitoring Associate/臨床研究監(jiān)查助理CRComplete Response痊愈CRAC

3、linical 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/臨床研究報告CTAClinical Trial Assistant (equivalent

4、 to Clinical Research Assistant)臨床研究助理CTAClinical Trial Agreement/臨床試驗協(xié)議CTAClinical Trial Application/臨床試驗申請CTSClinical Trial Supplies/臨床試驗用品CTXClinical Trial Exemption/臨床試驗免責(zé)CVCurriculum Vitae/履歷DCFData Clarification Form /數(shù)據(jù)澄清表DCRData Clarification Report (see DCF)/數(shù)據(jù)澄清報告DCRFData Clarification and

5、 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eCRFElectronic Case Report Form/電子病歷報告表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 an

6、d Drug Administration/美國食品藥品管理局FMApproved Standard Form/批準(zhǔn)的標(biāo)準(zhǔn)表格GCPGood Clinical Practice/臨床試驗質(zhì)量管理規(guī)范GLPGood Laboratory Practice /實驗室質(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)計質(zhì)量管理規(guī)范HCOHead of Clinical Operations臨床運營總監(jiān)IBInvestigato

7、rs Brochure/研究者手冊ICInformed Consent/ 知情同意ICFInformed Consent Form (also see IC)/知情同意書ICHInternational Conference on Harmonization/國際協(xié)調(diào)會議ICH-GCPInternational Conference on Harmonisation Tripartite Guideline on Good Clinical Practice國際協(xié)調(diào)會議藥品臨床試驗質(zhì)量管理規(guī)范指南IDBInvestigational Drug Brochure /試驗藥物手冊IECIndepe

8、ndent Ethic Committee/獨立倫理委員會INDInvestigational New Drug (US FDA)/研究用新藥IPInvestigational Product/研究用產(chǎn)品IRAEsImmediately Reportable Adverse Events/立即上報的不良事件IRBInstitutional Review Board. /機構(gòu)審查委員會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 M

9、anager/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)實體NCSNot Clinically Significant/無臨床意義NDNot Done/未做NDANew Drug Application./新藥上市申請ODOther Documents/其他文件OPOpe

10、rating Procedure/操作規(guī)程OOSOut Of Scope/超工作范圍OSOverall Survival/總體生存期OTLOperational Team Lead/運營團隊負(fù)責(zé)人PDProtocol Deviation/方案偏離PIPrinciple Investigator /主要研究者 PINPersonal Identification Number/個人確認(rèn)密碼PKPharmacokinetics/藥物代謝動力學(xué)PMProject Manager/項目經(jīng)理PMFProject Managerment File/項目管理文件夾PMIPeriodic Maintenanc

11、e Inspection/定期維護檢查PMSPost-Marketing Surveillance/上市后藥物檢測PPProject Plan/項目計劃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/遠程監(jiān)查On-Site Monitoring/現(xiàn)場監(jiān)查=On-Target Monitoring/目標(biāo)化監(jiān)查SAESerious Adverse Event /嚴(yán)

12、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/國家食品藥品監(jiān)督管理局SICSubject Identification Code/受試者識別代碼SIFSite Infor

13、mation Form/中心信息表SIVSite Initiation Visit/中心啟動訪視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/試驗主文檔UADRUnexpected Adverse Drug Reaction/非預(yù)期藥物不良反應(yīng)UADEUnanticipated ad

14、verse 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 BiostatisticsBD 業(yè)務(wù)拓展Business D

15、evelopmentCM 臨床監(jiān)查/運營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 項目管理 Project ManagementQA 質(zhì)量保證 Quality AssuranceRM 記錄管理 Records ManagementRA 注冊事務(wù)Regulatory AffairsSM SOP 管理SOP ManagementST 研究中心管理服務(wù)Site Management ServiceTR 培訓(xùn) Training試驗主文檔：（TMF） Trial Master FileP