臨床試驗常用的英文縮寫

實用文檔專業(yè)術語縮略語英文全稱 中文全稱ADE Adverse Drug Event 藥物不良事件ADR Adverse Drug Reaction 藥物不良反應AE Adverse Event 不良事件AI Assistant Investigator助理研究者BMI Body Mass Index 體質指數CI Co-investigator 合作研究者COI Coordinating Investigator 協調研究者CRAClinical Research Associate 臨床監(jiān)查員（臨床監(jiān)察員）CRC Clinical Research Coordinator 臨床研究協調者CRF Case Report Form 病歷報告表CRO Contract Research Organization 合同研究組織CSAClinical Study Application 臨床研究申請CTAClinical 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 Trial Report 臨床試驗報告DSMBData Safety and monitoring Board數據安全及監(jiān)控委員會EDC Electronic Data Capture 電子數據采集系統EDP Electronic Data Processing 電子數據處理系統FDA Food and Drug Administration 美國食品與藥品管理局FR Final Report 總結報告GCPGood Clinical Practice 藥物臨床試驗質量管理規(guī)范GLP Good Laboratory Practice 藥物非臨床試驗質量管理規(guī)范GMPGood Manufacturing Practice 藥品生產質量管理規(guī)范IB Investigators Brochure 研究者手冊IC Informed Consent 知情同意ICF Informed Consent Form 知情同意書ICH International Conference on Harmonization國際協調會議IDM Independent Data Monitoring 獨立數據監(jiān)察IDMC Independent Data Monitoring Committee獨立數據監(jiān)察委員會IEC Independent Ethics Committee 獨立倫理委員會IND Investigational New Drug 新藥臨床研究IRB Institutional Review Board 機構審查委員會IVD In Vitro Diagnostic 體外診斷IVRS Interactive Voice Response System互動語音應答系統MA Marketing Approval/Authorization上市許可證MCA Medicines Control Agency 英國藥品監(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NEC New Drug Entity 新化學實體NIH National Institutes of Health 國家衛(wèi)生研究所（美國）PI Principal Investigator 主要研究者PL Product License 產品許可證PMA Pre-market Approval (Application)上市前許可（申請）PSI Statisticians in the Pharmaceutical Industry 制藥業(yè)統計學家協會QA Quality Assurance 質量保證QC Quality Control 質量控制RA Regulatory Authorities 監(jiān)督管理部門SA Site Assessment 現場評估SAE Serious Adverse Event 嚴重不良事件SAP Statistical Analysis Plan 統計分析計劃SAR Serious Adverse Reaction 嚴重不良反應SD Source Data/Document 原始數據/文件SD Subject 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 原始數據核準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 Conference of Drug Regulatory AuthoritiesWHO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 稽查報告Auditor 稽查員Blank Control 空白對照Blinding/masking 盲法/設盲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 協調委員會Cross-over Study 交叉研究Double Blinding 雙盲Endpoint Criteria/measurement 終點指標Essential Documentation 必需文件Exclusion Criteria 排除標準Inclusion Criteria 入選表準Information Gathering 信息收集Initial Meeting 啟動會議Inspection 檢察/視察Institution Inspection 機構檢察Investigational Product 試驗藥物Investigator 研究者Monitor 監(jiān)查員（監(jiān)察員）Monitoring 監(jiān)查（監(jiān)察）Monitoring Plan 監(jiān)查計劃（監(jiān)察計劃）Monitoring Report 監(jiān)查報告（監(jiān)察報告）Multi-center Trial 多中心試驗Non-clinical Study 非臨床研究Original Medical Record 原始醫(yī)療記錄Outcome Assessment 結果評價Patient File 病人檔案Patient History 病歷Placebo 安慰劑Placebo Control 安慰劑對照Preclinical Study 臨床前研究Protocol 試驗方案Protocol Amendments 修正案Randomization 隨機Reference Product 參比制劑Sample Size 樣本量、樣本大小Seriousness 嚴重性Severity 嚴重程度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受試者識別代碼表Subject Recruitment 受試者招募Study Site 研究中