1、iiw：建滋囊姦丿貝腳內容縮略語英文全稱DCF data clarification formSDV source data verificationADE Adverse Drug EventADR Adverse Drug ReactionAEAdverse EventAlAssistant InvestigatorBMI Body Mass IndexCI Co-investigatorCOI Coordinating InvestigatorCRA Clinical Research AssociateCRCCRFCROClinical Research CoordinatorCase

2、 Report Form專業術語中文全稱數據澄淸表，用于紙質query原始數據核對藥物不良事件藥物不良反應不良事件助理研究者體質指數合作研究者協調研究者臨床監查員（臨床監察員）臨床研究協調者Contract Research Organization病歷報告表合同研究組織CSA Clinical Study ApplicationCTA Clinical Trial ApplicationCTXClinical Trial ExemptionCTPClinical Trial ProtocolCTRClinical Trial Report臨床研究申請臨床試驗申請臨床試驗免責臨床試驗方案臨床試

3、驗報告DSMB Data Safety and monitoring Board 數據安全及監控委員會EDC Electronic Data Capture電子數據采集系統EDPElectronic Data Processing電子數拯處理系統FDAFood and Dnig Administration美國食品與藥品管理局FRFinal Report總結報告GCP Good Clinical Practice藥物臨床試驗質量管理規范GLPGood Laboratory Practice藥物非臨床試驗質量管理規范GMP Good Manufacturing Practice藥品生產質量管理規

4、范IBInvestigator's Brochure研究者手冊ICInformed Consent知情同意ICFInformed Consent Form知情同意書ICHInternational Conference onHarmonization國際協調會議IDMIndependent Data Monitoring獨立數據監察IDMCIndependent Data Monitoring Committee 獨立數據監察委員會IECIndependent Ethics Committee獨立倫理委員會INDInvestigational New Drug新藥臨床研究IRBInst

5、itutional Review Board機構審查委員會IVDIn Vitro Diagnostic體外診斷IVRSInteractive Voice Response System 互動語音應答系統MAMarketing Approval/Authorization 上市許可證MCAMedicines Control Agency'英國藥品監督局MHWMinistry of Health and Welfare日本衛生福利部NDANew Drug Application新藥申請NECNew Drug Entity新化學實體NIHNational Institutes of Heal

6、th1國家衛生研究所（美國）PIPrincipal Investigator主要研究者PLProduct License產品許可證PMAPre-market Approval (Application)上市前許可(申 in )PSIStatisticians in the Pharmaceutical Industry 制藥業統計學家協會iiw：建滋囊姦丿QAQuality Assurance質量保證QCQuality Control質量控制RARegulatory Authorities監督管理部門SASite Assessment現場評估SAESerious Adverse Event嚴重

7、不良事件SAPStatistical Analysis Plan統計分析計劃SARSerious Adverse Reaction嚴重不良反應SDSource Data/Document原始數據/文件SDSubject Diary受試者日記SFDAState Food and Drug Administration國家食品藥品監督管理局SDVSource Data Verification原始數據核準SELSubject Enrollment Log受試者入選表SISub-investigator助理研究者SISponsor-Investigator申辦研究者SICSubject Identi

8、fication Code受試者識別代碼SOPStandard Operating Procedure 標準操作規程SPLStudy Personnel List研究人員名單SSLSubject Screening Log受試者篩選表T&RTest and Reference Product受試和參比試劑UAEUnexpected Adverse Event預料外不良事件WHOWorld Health Organization世界衛生組織WHO-ICDRA WHO International Conference of Drug Regulatory Authorities WHO 國

9、際藥品 管理當局會議貝腳內容Active ControlAuditAudit ReportAuditorBlank Control陽性對照、活性對照稽査稽查報告稽査員空白對照Blinding/maskingCase HistoryClinical studyClinical TrialClinical Trial ReportComplianceCoordinating CommitteeCross-over StudyDouble BlindingEndpoint Criteria/measurementEssential DocumentationExclusion CriteriaInc

10、lusion CriteriaInformation GatheringInitial MeetingInspectionInstitution InspectionInvestigational ProductInvestigatorMonitorMonitoringMonitoring PlanMonitoring ReportMulti-center TrialNon-clinical StudyOriginal Medical RecordOutcome AssessmentPatient FilePatient HistoryPlaceboPlacebo ControlPreclin

11、ical StudyProtocolProtocol AmendmentsRandomizationReference ProductSample SizeSeriousness盲法/設盲病歷臨床研究臨床試驗臨床試驗報告依從性協調委員會交叉研究雙盲終點指標必需文件排除標準入選表準信息收集啟動會議檢察/視察機構檢察試驗藥物研究者監査員（監察員）監査（監察）監查計劃（監察計劃） 監査報告（監察報告） 多中心試驗 非臨床研究 原始醫療記錄結果評價病人檔案病歷安慰劑安慰劑對照臨床前研究試驗方案修正案隨機參比制劑樣本量、樣本大小嚴重性SeveritySingle BlindingSponsorStudy AuditSubjectSubject EnrollmentSubject Enrollment Log嚴重程度單盲申辦者研究稽查受試者受試者入選受試者入選表Subject Identification Code List 受試者識別代碼表Subject RecniitmentStudy SiteSubject