學習資料收集于網絡，僅供參考臨床研究常用術語縮寫表編號術語縮寫英文全稱/中文全稱ADRAdverse drug reaction/不良反應AEAdverse Event/不良事件ASVAccompanied Site Visit/陪同訪視BD業務拓展Business DevelopmentBS生物統計 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Co-ICoordinating Investigator負責協調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/臨床監查/運營CMAClinical Monitoring Associate/臨床研究監查助理CRComplete Response痊愈CRAClinical Research Associate (equivalent to Clinical Study Monitor)臨床監查員CRCClinical Research Coordinator/臨床研究協調員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 to Clinical Research Assistant)臨床研究助理CTAClinical Trial Agreement/臨床試驗協議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CVCurriculum Vitae/履歷DCFData Clarification Form /數據澄清表DCRData Clarification Report (see DCF)/數據澄清報告DCRFData Clarification and Resolution Form (see DCF)/數據澄清和解決表DMData Management/數據管理DMPData Management Plan/數據管理計劃書DQFData Query Form/數據疑問表DSData Source/數據源ECEthics Committee /倫理委員會eCRFElectronic Case Report Form/電子病歷報告表EDCElectronic Data Capture/電子數據采集EOSEnd of Study/研究結束EUEuropean Union/歐盟FASFull Analysis Set/全分析集FDAFood and Drug Administration/美國食品藥品管理局FMApproved Standard Form/批準的標準表格GCPGood Clinical Practice/臨床試驗質量管理規范GLPGood Laboratory Practice /實驗室質量管理規范GMPGood Manufacturing Practice/藥品生產質量管理規范GRPGood Research Practice/科學研發質量管理規范GSPGood Statistical Practice/統計質量管理規范HCOHead of Clinical Operations臨床運營總監IBInvestigators 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/國際協調會議ICH-GCPInternational Conference on Harmonisation Tripartite Guideline on Good Clinical Practice國際協調會議藥品臨床試驗質量管理規范指南IDBInvestigational Drug Brochure /試驗藥物手冊IECIndependent Ethic Committee/獨立倫理委員會INDInvestigational New Drug (US FDA)/研究用新藥IPInvestigational Product/研究用產品IRAEsImmediately Reportable Adverse Events/立即上報的不良事件IRBInstitutional Review Board. /機構審查委員會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 Manager/直線經理LOILetter of Intent/意向書MOHMinistry of Health/衛生部MSAMaster Services Agreement/主服務協議MTDMaximum Tolerated Dose/最大耐受劑量MWMedical Writing/醫學寫作NANot Available/不可用NCENew Chemical Entity/新化學實體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OPOperating Procedure/操作規程OOSOut Of Scope/超工作范圍OSOverall Survival/總體生存期OTLOperational Team Lead/運營團隊負責人PDProtocol Deviation/方案偏離PIPrinciple Investigator /主要研究者 PINPersonal Identification Number/個人確認密碼PKPharmacokinetics/藥物代謝動力學PMProject Manager/項目經理PMFProject Managerment File/項目管理文件夾PMIPeriodic Maintenance 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/質量管理QCQuality Control/質量控制RARegulatory Authorities/監督管理部門RMRemote Monitoring/遠程監查On-Site Monitoring/現場監查=On-Target Monitoring/目標化監查SAESerious Adverse Event /嚴重不良事件SCStudy Coordinator/研究協調員SCVSite Close-out Visit/中心關閉訪視SSVSite Selection Visit/中心篩選訪視SMVSite Monitoring Visit/中心監查訪視SVRSite Visit Report/中心訪視報告SDSource Data/源數據SDVSource Data Verification/原始數據核查SFDAState Food and Drug Administration/國家食品藥品監督管理局SICSubject Identification Code/受試者識別代碼SIFSite Information Form/中心信息表SIVSite Initiation Visit/中心啟動訪視SOPStandard Operating Procedure/標準操作規程SOWScope of Work/工作范圍Sub-ISubinvestigator次要研究者SUSARSuspected Unexpected Serious Adverse Reaction可疑的非預期的嚴重不良反應TPTemplate/模版TMFTrial Master File/試驗主文檔UADRUnexpected Adverse Drug Reaction/非預期藥物不良反應UADEUnanticipated adverse drug effect/非預期的不良反應UAEUnexpected adverse event/非預期的不良事件WIWork Instruction/工作指南SOP 類型縮寫表OP 操作規程 Operating ProceduresWI 工作指南 Work InstructionsTP 模板 TemplateFM 批準的標準表格 Approved Standard FormsOD 其他文件 Other Documents業務部門縮寫表/ Functional Area Abbreviation Table:BS 生物統計 BiostatisticsBD 業務拓展Business DevelopmentCM 臨床監查/運營Clinical Monitoring/OperationDM 數據管理 Data ManagementIT 信息技術 Information TechnologyMS 醫學科學服務Medical Science ServicePM 項目管理 Project ManagementQA 質量保證 Quality AssuranceRM 記錄管理 Records ManagementRA 注冊事務Regulatory AffairsSM SOP 管理SOP ManagementST 研究中心管理服務Site Management ServiceTR 培訓 Training試驗主文檔：（TMF） Trial Mas