臨床試驗(yàn)常用的英文縮寫

1、創(chuàng)作：歐陽(yáng)學(xué)時(shí)間:2021.03. 03縮略語(yǔ)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(duì)SDV source data verificationADE Adverse Drug Event藥物不良事件藥物不良反應(yīng)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(bào)告表CRO Contract Research Organization合同研究組織CSA Clinical Study Application臨味研究申請(qǐng)CTA Clinical Trial Application臨床試驗(yàn)申請(qǐng)CTX Clinical Trial Exemption臨床試驗(yàn)免責(zé)CTP Clinical Trial Protocol臨床試驗(yàn)方案CTR Clinical Tria

3、l Report臨床試驗(yàn)報(bào)告DSMB Data Safety and monitoring Board 數(shù)據(jù)安全及監(jiān)控委員會(huì)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(guó)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(bào)告藥物臨床試驗(yàn)質(zhì)

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

5、gational New Drug新藥臨床研究IRB Institutional Review Board機(jī)構(gòu)審查委員會(huì)IVD In Vitro Diagnostic體外診斷IVRS Interactive Voice Response System 互動(dòng)語(yǔ)音應(yīng)答系 統(tǒng)MAMarketing Approval/Authorization 上市許可證MCA Medicines Control Agency英國(guó)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(qǐng)NEC New Drug Entity新

6、化學(xué)實(shí)體NIH National Institutes of Health國(guó)家衛(wèi)生研究所（美國(guó)）主要研究者PI Principal InvestigatorPL Product License嚴(yán)品許可證PMA Pre-market Approval (Application)上市前許可(申 請(qǐng))PSI Statisticians in the Pharmaceutical Industry 制藥業(yè)統(tǒng) 計(jì)學(xué)家協(xié)會(huì)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(chǎng)

7、評(píng)估SAESerious Adverse Event嚴(yán)瑩不良事件SAPStatistical Analysis Plan統(tǒng)計(jì)分析計(jì)劃SARSerious Adverse Reaction嚴(yán)遠(yuǎn)不良反應(yīng)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(guó)家食品藥品監(jiān)督管理局SDV Source Data Verification原始數(shù)據(jù)核準(zhǔn)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(shí)別代碼SOP Standard Operating Procedure 標(biāo)準(zhǔn)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(yù)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(guó)際藥品管理當(dāng)局會(huì)議Active Control陽(yáng)性對(duì)照、活性對(duì)照Audit稽查Audit Report稽查報(bào)吿Auditor稽查員Blank Control空白對(duì)照Blinding/masking盲法/設(shè)盲Case History病歷Clinical study臨床研究Clinical Trial臨床試驗(yàn)Clinical Trial Report臨床試驗(yàn)報(bào)告Compliance依從性Coordinating Committee協(xié)調(diào)委員會(huì)Cross-over Study交叉研究Double Blinding雙盲End

10、point Criteria/measurement 終點(diǎn)指標(biāo)研究者監(jiān)查員（監(jiān)察員）監(jiān)查（監(jiān)察）監(jiān)查計(jì)劃（監(jiān)察計(jì)劃）監(jiān)查報(bào)吿（監(jiān)察報(bào)告）多中丿試驗(yàn)WE臨床研究原始醫(yī)療記錄結(jié)果評(píng)價(jià)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(biāo)準(zhǔn)入選表準(zhǔn)信息收集啟動(dòng)會(huì)議檢察/視察機(jī)構(gòu)檢察試驗(yàn)藥物病歷安慰劑安慰劑對(duì)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