臨床試驗(yàn)常用的英文縮寫

實(shí)用文檔專業(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ADR Adverse Drug Reaction 藥物不良反應(yīng)AE Adverse Event 不良事件AI Assistant Investigator助理研究者BMI Body Mass Index 體質(zhì)指數(shù)CI Co-investigator 合作研究者COI Coordinating Investigator 協(xié)調(diào)研究者CRAClinical Research Associate 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CSAClinical Study Application 臨床研究申請(qǐng)CTAClinical 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 Trial Report 臨床試驗(yàn)報(bào)告DSMBData 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 Report 總結(jié)報(bào)告GCPGood Clinical Practice 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)范GMPGood Manufacturing Practice 藥品生產(chǎn)質(zhì)量管理規(guī)范IB Investigators 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(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)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 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)MA Marketing Approval/Authorization上市許可證MCA Medicines Control Agency 英國(guó)藥品監(jiān)督局MHW Ministry of Health and Welfare 日本衛(wèi)生福利部NDA New Drug Application 新藥申請(qǐng)NEC New Drug Entity 新化學(xué)實(shí)體NIH National Institutes of Health 國(guó)家衛(wèi)生研究所（美國(guó)）PI 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RA Regulatory Authorities 監(jiān)督管理部門SA Site Assessment 現(xiàn)場(chǎng)評(píng)估SAE Serious Adverse Event 嚴(yán)重不良事件SAP Statistical Analysis Plan 統(tǒng)計(jì)分析計(jì)劃SAR Serious Adverse Reaction 嚴(yán)重不良反應(yīng)SD Source Data/Document 原始數(shù)據(jù)/文件SD Subject 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-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 Conference of Drug Regulatory AuthoritiesWHO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)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 Criteria/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）Multi-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 臨床前研究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 單盲Sponsor 申辦者Study Audit 研究稽查Subject 受試者Subject Enrollment 受試者入選Subject Enrollment Log 受試者入選表Subject Identification Code List受試者識(shí)別代碼表Subject Recruitment 受試者招募Study Site 研究中