臨床試驗(yàn)常用的英文縮寫

1、百度文庫-讓每個(gè)人平等地提升自我專業(yè)術(shù)語7Clinical Research Coordinator臨床研究協(xié)調(diào)者Case Report Form病歷報(bào)告表Contract Research Organization 合同研究組織縮略語英文全稱DCF data clarification formSDV source data verificationADE Adverse Drug EventADR Adverse Drug ReactionAEAdverse EventAIAssistant InvestigatorBMI Body Mass IndexCI Co-investigator

2、COI Coordinating InvestigatorCRA Clinical Research AssociateCRCCRFCROCSA Clinical Study ApplicationCTA Clinical Trial ApplicationCTXClinical Trial ExemptionCTPClinical Trial ProtocolCTRClinical Trial Report中文全稱數(shù)據(jù)澄清表，用于紙質(zhì) query原始數(shù)據(jù)核對(duì)藥物不良事件藥物不良反應(yīng)不良事件助理研究者體質(zhì)指數(shù)合作研究者協(xié)調(diào)研究者臨床監(jiān)查員（臨床監(jiān)察員）臨床研究申請(qǐng)臨床試驗(yàn)申請(qǐng)臨床試驗(yàn)免責(zé)臨床試

3、驗(yàn)方案臨床試驗(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美國食品與藥品管理局FR Final ReportGCP Good Clinical PracticeGLP Good Laboratory PracticeGMP Good Manufacturing Practice總結(jié)報(bào)告藥物臨床試驗(yàn)質(zhì)量管理規(guī)范藥物非臨床試驗(yàn)質(zhì)量管理規(guī)

4、范藥品生產(chǎn)質(zhì)量管理規(guī)范舊 Investigator ' s Brochure 研究者手冊(cè)IC Informed Consent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(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)察委員會(huì)IEC Independent Ethics Committee獨(dú)立倫理委員會(huì)IND Investigationa

5、l 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)語音應(yīng)答系統(tǒng)英國藥品監(jiān)督局日本衛(wèi)生福利部新藥申請(qǐng)新化學(xué)實(shí)體國家衛(wèi)生研究所（美國）MA Marketing Approval/Authorization 上市許可證MCA Medicines Control AgencyMHW Ministry of Health and WelfareNDANew Drug ApplicationNECNew Drug

6、EntityNIH National Institutes of HealthPI Principal Investigator主要研究者PL Product License產(chǎn)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)QA Quality Assurance質(zhì)量保證QC Quality Control質(zhì)量控制State Food and Drug AdministrationRARegulatory Authoritie

7、sSASite AssessmentSAE Serious Adverse EventSAP Statistical Analysis PlanSAR Serious Adverse ReactionSDSource Data/DocumentSDSubject DiarySFDA監(jiān)督管理部門現(xiàn)場(chǎng)評(píng)估嚴(yán)重不良事件統(tǒng)計(jì)分析計(jì)劃嚴(yán)重不良反應(yīng)原始數(shù)據(jù)/文件受試者日記國家食品藥品監(jiān)督管理局SDVSource Data VerificationSELSubject Enrollment LogSI Sub-investigatorSI Sponsor-InvestigatorSIC Subject Id

8、entification CodeSOP Standard Operating ProcedureSPL Study Personnel ListSSL Subject Screening LogT&RTest and Reference ProductUAEUnexpected Adverse EventWHO World Health OrganizationWHO-ICDRA管理當(dāng)局會(huì)議原始數(shù)據(jù)核準(zhǔn)受試者入選表助理研究者申辦研究者受試者識(shí)別代碼標(biāo)準(zhǔn)操作規(guī)程研究人員名單受試者篩選表受試和參比試劑預(yù)料外不良事件世界衛(wèi)生組織WHO International Conference of

9、 Drug Regulatory Authorities WHO國際藥品Active Control陽性對(duì)照、活性對(duì)照Audit稽查Audit Report稽查報(bào)告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Endpoint Criteri

10、a/measurement終點(diǎn)指標(biāo)Essential Documentation必需文件Exclusion Criteria排除標(biāo)準(zhǔn)Inclusion Criteria入選表準(zhǔn)Information Gathering信息收集Initial Meeting啟動(dòng)會(huì)議Inspection檢察/視察Institution Inspection機(jī)構(gòu)檢察Investigational Product試驗(yàn)藥物Investigator研究者M(jìn)onitor監(jiān)查員（監(jiān)察員）Monitoring監(jiān)查（監(jiān)察）Monitoring Plan監(jiān)查計(jì)劃（監(jiān)察計(jì)劃）Monitoring Report監(jiān)查報(bào)告（監(jiān)察報(bào)告）Mu

11、lti-center Trial多中心試驗(yàn)Non-clinical Study非臨床研究Original Medical Record原始醫(yī)療記錄Outcome Assessment結(jié)果評(píng)價(jià)Patient File病人檔案Patient History病歷Placebo安慰劑Placebo Control安慰劑對(duì)照Preclinical Study愴林刖研究Protocol試驗(yàn)方案Protocol Amendments修正案Randomization隨機(jī)Reference Product參比制劑Sample Size樣本量、樣本大小Seriousness嚴(yán)重性Severity嚴(yán)重程度Single Blinding單旨Sponsor申辦者Study AuditSubjectSubject EnrollmentSubject Enrollment LogSubject Identification Code ListSubject RecruitmentStudy SiteSubject Screening LogSystem AuditTest