臨床試驗常用的英文縮寫

1、創(chuàng)作：歐陽學時間:2021.03. 03縮略語英文全稱中文全稱DCF data clarification form數(shù)據(jù)澄清表，用于紙質(zhì)query原始數(shù)據(jù)核對SDV source data verificationADE Adverse Drug Event藥物不良事件藥物不良反應AE Adverse Event不良事件ADR Adverse Drug Reaction助理研究者Al Assistant InvestigatorBMI Body Mass Index體質(zhì)指數(shù)COI Coordinating InvestigatorCRA Clinical Research AssociateC

2、I Co-investigator合作研究者協(xié)調(diào)研究者臨床監(jiān)查員（臨床監(jiān)察員）CRC Clinical Research Coordinator臨床研究協(xié)調(diào)者CRF Case Report Form病歷報告表CRO Contract Research Organization合同研究組織CSA Clinical Study Application臨味研究申請CTA Clinical Trial Application臨床試驗申請CTX Clinical Trial Exemption臨床試驗免責CTP Clinical Trial Protocol臨床試驗方案CTR Clinical Tria

3、l Report臨床試驗報告DSMB Data Safety and monitoring Board 數(shù)據(jù)安全及監(jiān)控委員會EDC Electronic Data Capture電子數(shù)據(jù)采集系統(tǒng)EDP Electronic Data Processing電子數(shù)據(jù)處理系統(tǒng)FDA Food and Drug Administration美國食品與藥品管理局FR Final ReportGCP Good Clinical Practice 理規(guī)范GLP Good Laboratory Practice 管理規(guī)范GMP Good Manufacturing Practice 規(guī)范總結(jié)報告藥物臨床試驗質(zhì)

4、量管藥物非臨床試驗質(zhì)量藥品生產(chǎn)質(zhì)量管理IB Investigator's BrochureIC Informed Consent研究者手冊知情同意ICF Informed Consent Form知情同意書ICH International Conference on Harmonization 國 際協(xié)調(diào) 會議IDM Independent Data Monitoring 獨立數(shù)據(jù)監(jiān)察IDMC Independent Data Monitoring Committee 獨立數(shù)據(jù) 監(jiān)委員IEC Independent Ethics Committee獨立倫理委員會IND Investi

5、gational New Drug新藥臨床研究IRB Institutional Review Board機構(gòu)審查委員會IVD In Vitro Diagnostic體外診斷IVRS Interactive Voice Response System 互動語音應答系 統(tǒng)MAMarketing Approval/Authorization 上市許可證MCA Medicines Control Agency英國藥品監(jiān)替局MHW Ministry of Health and Welfare 日本衛(wèi)生福利 部NDANew Drug Application新藥申請NEC New Drug Entity新

6、化學實體NIH National Institutes of Health國家衛(wèi)生研究所（美國）主要研究者PI Principal InvestigatorPL Product License嚴品許可證PMA Pre-market Approval (Application)上市前許可(申 請)PSI Statisticians in the Pharmaceutical Industry 制藥業(yè)統(tǒng) 計學家協(xié)會QAQuality Assurance質(zhì)量保證QCQuality Control質(zhì)量控制RARegulatory Authorities監(jiān)督管理部門SASite Assessment現(xiàn)場

7、評估SAESerious Adverse Event嚴瑩不良事件SAPStatistical Analysis Plan統(tǒng)計分析計劃SARSerious Adverse Reaction嚴遠不良反應SDSource Data/Document原始數(shù)據(jù)/文件SDSubject Diary受試者日記SFDA State Food and Drug Administration 國家食品藥品監(jiān)督管理局SDV Source Data Verification原始數(shù)據(jù)核準SEL Subject Enrollment Log受試者入選表SI Sub-investigator助理研究者SI Sponsor-

8、Investigator申辦研究者SIC Subject Identification Code受試者識別代碼SOP Standard Operating Procedure 標準操作規(guī)程SPL Study Personnel List研究人員名單SSL Subject Screening Log受試者篩選表T&R Test and Reference Product受試和參比試劑UAE Unexpected Adverse Event預料外不良事件WHO World Health Organization世界衛(wèi)生組織WHO-ICDRA WHO International Confer

9、ence of Drug Regulatory Authorities WHO國際藥品管理當局會議Active Control陽性對照、活性對照Audit稽查Audit Report稽查報吿Auditor稽查員Blank Control空白對照Blinding/masking盲法/設(shè)盲Case History病歷Clinical study臨床研究Clinical Trial臨床試驗Clinical Trial Report臨床試驗報告Compliance依從性Coordinating Committee協(xié)調(diào)委員會Cross-over Study交叉研究Double Blinding雙盲End

10、point Criteria/measurement 終點指標研究者監(jiān)查員（監(jiān)察員）監(jiān)查（監(jiān)察）監(jiān)查計劃（監(jiān)察計劃）監(jiān)查報吿（監(jiān)察報告）多中丿試驗WE臨床研究原始醫(yī)療記錄結(jié)果評價病人檔案Essential DocumentationExclusion CriteriaInclusion CriteriaInformation GatheringInitial MeetingInspectionInstitution InspectionInvestigational ProductInvestigatorMonitorMonitoringMonitoring PlanMonitoring Re

11、portMulti-center TrialNon-clinical StudyOriginal Medical RecordOutcome AssessmentPatient FilePatient HistoryPlaceboPlacebo ControlPreclinical Study必需文件須E除標準入選表準信息收集啟動會議檢察/視察機構(gòu)檢察試驗藥物病歷安慰劑安慰劑對照臨床前研究ProtocolProtocol AmendmentsRandomizationReference ProductSample SizeSeriousnessSeveritySingle BlindingSponsorStudy AuditSubjectSubject EnrollmentSubject Enrollment LogSubject Identification Code ListSubject RecruitmentStudy SiteSubject Screening LogSystem AuditTest ProductTrial Initial MeetingTrial Mast