臨床試驗(yàn)常用術(shù)語(yǔ)縮寫

1、專業(yè)術(shù)語(yǔ) 縮略語(yǔ) 英文全稱 中文全稱 ADE Adverse Drug Event 藥物不良事件 反應(yīng)AE Adverse Event 不良事件 者BMI Body Mass Index 體質(zhì)指數(shù) COI Coordinating Investigator CRA Clinical Research Associate CRC Clinical Research Coordinator 表CRO Contract Research Organization CSAClinical Study Application 床試驗(yàn)申請(qǐng)ADR Adverse Drug ReactionAI Assist

2、ant Investigator藥物不良助理研究CI Co-investigator 協(xié)調(diào)研究者 臨床監(jiān)查員 （ 臨床監(jiān)察員 ） 臨床研究協(xié)調(diào)者 CRF Case Report Form 病歷報(bào)告合作研究者合同研究組織 ECRF 電子化病歷報(bào)告表 臨床研究申請(qǐng) CTA Clinical Trial Application 臨CTXClinical Trial Exemption 臨床試驗(yàn)免責(zé) 床試驗(yàn)方案CTPClinical Trial Protocol 臨CTR Clinical Trial Report臨床試驗(yàn)報(bào)告DSMB Data Safety and monitoring Board數(shù)

3、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 Report 告GCP Good Clinical Practice總結(jié)報(bào)藥物臨床試驗(yàn)質(zhì)量管理規(guī)范 GLP Good Laboratory Practice藥物非臨床試驗(yàn)質(zhì)量管理規(guī)GMP Good Manufacturing Practice 藥品生產(chǎn)質(zhì)量管理規(guī)范 IB Investigator s Brochure 研究者手冊(cè)

4、 IC Informed Consent 同意 ICF Informed Consent Form知情同意書 ECG ElectrocardiogramICH International Conference on Harmonization國(guó)際協(xié)調(diào)會(huì)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 Investigational New Drug新藥臨床研究 IRB Inst

5、itutional Review Board查委員會(huì) IVD In Vitro Diagnostic 市許可證體外診斷IVRS Interactive Voice Response System MCA Medicines Control Agency MHW Ministry of Health and Welfare 藥申請(qǐng)心電圖MA Marketing Approval/Authorization互動(dòng)語(yǔ)音應(yīng)答系統(tǒng)英國(guó)藥品監(jiān)督局日本衛(wèi)生福利部 NDA New Drug ApplicationNEC New Drug Entity 新化學(xué)實(shí)體 NIH National Institutes

6、of Health 所（ 美國(guó) ） PI Principal Investigator 品許可證主要研究者PL Product License知情機(jī)構(gòu)審國(guó)家衛(wèi)生研究PMA Pre-market Approval (Application)PSI Statisticians in the Pharmaceutical IndustryQA Quality Assurance 質(zhì)量保證 控制RA Regulatory Authorities 評(píng)估SAE Serious Adverse Event 分析計(jì)劃上市前許可 （ 申請(qǐng) ）制藥業(yè)統(tǒng)計(jì)學(xué)家協(xié)會(huì)QC Quality Control質(zhì)量監(jiān)督管理部門

7、嚴(yán)重不良事件SA SiteAssessment 現(xiàn)場(chǎng)SAP Statistical Analysis Plan統(tǒng)計(jì)SAR Serious Adverse Reaction 嚴(yán)重不良反應(yīng) 文件SD Subject Diary 受試者日記Subject identification code (SIC)SFDA State Food and Drug Administration 國(guó)家食品藥品監(jiān)督管理局SD Source Data/Document原始數(shù)據(jù) /受試者識(shí)別代碼SDV Source Data Verification原始數(shù)據(jù)核準(zhǔn) SEL Subject Enrollment Log者入

8、選表SI Sub-investigator 助理研究者 研究者SIC Subject Identification Code 動(dòng)力學(xué)SOP Standard Operating Procedure 力學(xué)受試SI受試者識(shí)別代碼標(biāo)準(zhǔn)操作規(guī)程SPL Study Personnel List研究人員名單者篩選表T&R Test and Reference ProductSponsor-Investigatorpd pharmacodynamicspk pharmacokineticsSSL Subject Screening Log受試和參比試劑 預(yù)料外不良事件 世界衛(wèi)生組織UAE Unexpecte

9、d Adverse Event WHO World Health Organization 對(duì)照WHO-ICDRA WHO International Conference of Drug Regulatory Authorities WHO 品 管理當(dāng)局會(huì)議Unexpected adverse event (UAE)Audit 稽查 Audit Report稽查報(bào)告 Auditor照 八、Blinding/masking 盲法 / 設(shè)盲 Case History Clinical Trial 臨 床 試 驗(yàn) Clinical Compliance 依從性Coordinating Commit

10、tee 協(xié)調(diào)委員會(huì) Cross-over 雙盲Active Control申辦藥物效應(yīng)藥物代謝動(dòng)受試陽(yáng)性對(duì)照、活性國(guó)際藥預(yù)料外不良事件稽查員 Blank Control病歷Trial ReportClinical studyStudy 交叉研究空白對(duì)臨床研究臨床試驗(yàn)報(bào)告Double BlindingEndpoint Criteria/measurement終點(diǎn)指標(biāo) Essential DocumentationExclusion Criteria 排 除 標(biāo) 準(zhǔn)Inclusion Criteria 入 選 表 準(zhǔn)Gathering 信息收集Initial Meeting 啟動(dòng)會(huì)議 Inspec

11、tion 構(gòu)檢察Investigational Product 察員)必需文件Information檢察 / 視察InstitutionInspection 機(jī)試驗(yàn)藥物 Investigator研究者 Monitor監(jiān)查員 （ 監(jiān)Monitoring 監(jiān)查 ( 監(jiān)察 ) Monitoring Plan監(jiān)查計(jì)劃（ 監(jiān)察計(jì)劃 ）Monitoring Report Non-clinical Study Outcome Assessment 結(jié)果評(píng)價(jià)Placebo Control Protocol AmendmentsPlacebo 安慰劑 Protocol 試驗(yàn)方案 Reference Produc

12、t 性Severity 嚴(yán)重程度 Study Audit 研究稽查 選Subject Enrollment Log監(jiān)查報(bào)告 ( 監(jiān)察報(bào)告 ) Multi-center Trial非臨床研究 Original Medical RecordPatient File病人檔案安慰劑對(duì)照 Preclinical Study多中心試驗(yàn)原始醫(yī)療記錄Patient History病歷臨床前研究隨機(jī)參比制劑 SampleSingle BlindingSubject別代碼表 Subject RecruitmentSystem AuditTrial Initial脫Trial Objective Alb 白蛋白修正

13、案 RandomizationSize 樣本量、樣本大小 Seriousness 嚴(yán)重單盲 Sponsor 申辦者 受試者 Subject Enrollment受試者入選表受試者招募 系統(tǒng)稽查 Study Site研究中心Meeting 試驗(yàn)啟動(dòng)會(huì)議 TrialSubject Identification Code List Subject Screening Log Test Product Master File 試驗(yàn)總檔案受試者入受試者識(shí) 受試者篩選表 受試制劑 Wash-out 洗洗脫期 堿性磷酸酶 批準(zhǔn)三盲 Wash-out Period ）近似致死劑量 丙氨酸氨基轉(zhuǎn)換酶 批準(zhǔn) AT

14、R試驗(yàn)?zāi)康?Triple BlindingALD ( Approximate Lethal DoseALTApproval AST 天門冬酸氨基轉(zhuǎn)換酶 Standard operating procedure (SOP)Alpha spending function 消耗函數(shù) Analysis sets 統(tǒng)計(jì)分析的數(shù)據(jù)集 Assistant investigator助理研究者AUCss穩(wěn)態(tài)血藥濃度時(shí)間曲線下面積規(guī)程ALPApproval 衰減全反射法標(biāo)準(zhǔn)操作Case report form/ case record form(CRF)Cli nical trial appi icati on(

15、CTA)臨床試驗(yàn)申請(qǐng)臨床試驗(yàn)免責(zé)Clinical trial protocol (CTP)合同研究組織病例報(bào)告表病例記錄表Clinicaltrial exemption臨床試驗(yàn)方案 Contract research organization (CRO)Computer-assisted trial design (CATD)始數(shù)據(jù)Electronic data capture (EDC)原始數(shù)據(jù)核準(zhǔn)Electronic data processing (EDP)試者入選表Institution review board (IBR)分析( 統(tǒng)計(jì)學(xué))計(jì)算機(jī)輔助試驗(yàn)設(shè)計(jì)Source data (SD)電子數(shù)據(jù)采集系統(tǒng) Source data verification (SDV)電子數(shù)據(jù)處理系統(tǒng) Subject enrollment log機(jī)構(gòu)審查委員會(huì) Intention-to-treat (ITT)Interactive voice response system (IVRS)互動(dòng)式語(yǔ)音應(yīng)答系統(tǒng)I