臨床試驗常用的英文縮寫

1、專業(yè)術(shù)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(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CRA Clinical 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

2、Case Report Form 病歷報告表CRO Contract Research Organization 合同研究組織CSA Clinical Study Application 臨床研究申請CTA Clinical Trial Application 臨床試驗申請CTX Clinical Trial Exemption 臨床試驗免責(zé)CTP Clinical Trial Protocol 臨床試驗方案CTR Clinical Trial Report 臨床試驗報告DSMB Data Safety and monitoring Board 數(shù)據(jù)安全及監(jiān)控委員會EDC Electronic

3、 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 Report 總結(jié)報告GCP Good Clinical Practice 藥物臨床試驗質(zhì)量管理規(guī)范GLP Good Laboratory Practice 藥物非臨床試驗質(zhì)量管理規(guī)范GMP Good Manufacturing Practice 藥品生產(chǎn)質(zhì)量管理規(guī)范IB Investigators Brochure研究者手冊IC Informed Consent 知情同

4、意ICF Informed Consent Form 知情同意書ICH International Conference on Harmonization 國際協(xié)調(diào)會議IDM Independent Data Monitoring 獨立數(shù)據(jù)監(jiān)察IDMC Independent Data Monitoring Committee 獨立數(shù)據(jù)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(gòu)審查委員會IVD In Vitro

5、Diagnostic 體外診斷IVRS Interactive Voice Response System 互動語音應(yīng)答系統(tǒng)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(xué)實體NIH National Institutes of Health 國家衛(wèi)生研究所(美國PI Principal Investig

6、ator 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PSI Statisticians in the Pharmaceutical Industry 制藥業(yè)統(tǒng)計學(xué)家協(xié)會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)場評估SAE Serious Adverse Event 嚴(yán)重不良事件SAP Statistical Analysis Pla

7、n 統(tǒng)計分析計劃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

8、 受試者識別代碼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 Authorities WHO國際藥

9、品管理當(dāng)局會議Active Control 陽性對照、活性對照Audit Report 稽查報告Auditor 稽查員Blank Control 空白對照Blinding/masking 盲法/設(shè)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(xié)調(diào)委員會Cross-over Study 交叉研究Double Blinding 雙盲Endpoint Criteria/measurement 終點指標(biāo)Essen

10、tial 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 啟動會議Inspection 檢察/視察Institution Inspection 機構(gòu)檢察Investigational Product 試驗藥物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)查計劃(監(jiān)察計劃 Monitoring Report 監(jiān)查報告(監(jiān)察報告 Multi-center

11、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(jié)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 受試者識別代碼表 Subject Recruitment 受試者招募Study Site 研究中