臨床試驗常用術語縮寫

1、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 反應AE Adverse Event 不良事件 者BMI Body Mass Index 體質指數(shù) COI Coordinating Investigator CRA Clinical Research Associate CRC Clinical Research Coordinator 表CRO Contract Research Organization CSAClinical Study Application 床試驗申請ADR Adverse Drug ReactionAI Assist

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

3、據(jù)安全及監(jiān)控委員會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 Report 告GCP Good Clinical Practice總結報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)GMP Good Manufacturing Practice 藥品生產(chǎn)質量管理規(guī)范 IB Investigator s Brochure 研究者手冊

4、 IC Informed Consent 同意 ICF Informed Consent Form知情同意書 ECG ElectrocardiogramICH International Conference on Harmonization國際協(xié)調會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 Inst

5、itutional Review Board查委員會 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 藥申請心電圖MA Marketing Approval/Authorization互動語音應答系統(tǒng)英國藥品監(jiān)督局日本衛(wèi)生福利部 NDA New Drug ApplicationNEC New Drug Entity 新化學實體 NIH National Institutes

6、of Health 所（ 美國 ） PI Principal Investigator 品許可證主要研究者PL Product License知情機構審國家衛(wèi)生研究PMA Pre-market Approval (Application)PSI Statisticians in the Pharmaceutical IndustryQA Quality Assurance 質量保證 控制RA Regulatory Authorities 評估SAE Serious Adverse Event 分析計劃上市前許可 （ 申請 ）制藥業(yè)統(tǒng)計學家協(xié)會QC Quality Control質量監(jiān)督管理部門

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

8、選表SI Sub-investigator 助理研究者 研究者SIC Subject Identification Code 動力學SOP Standard Operating Procedure 力學受試SI受試者識別代碼標準操作規(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 預料外不良事件 世界衛(wèi)生組織UAE Unexpecte

9、d Adverse Event WHO World Health Organization 對照WHO-ICDRA WHO International Conference of Drug Regulatory Authorities WHO 品 管理當局會議Unexpected adverse event (UAE)Audit 稽查 Audit Report稽查報告 Auditor照 八、Blinding/masking 盲法 / 設盲 Case History Clinical Trial 臨 床 試 驗 Clinical Compliance 依從性Coordinating Commit

10、tee 協(xié)調委員會 Cross-over 雙盲Active Control申辦藥物效應藥物代謝動受試陽性對照、活性國際藥預料外不良事件稽查員 Blank Control病歷Trial ReportClinical studyStudy 交叉研究空白對臨床研究臨床試驗報告Double BlindingEndpoint Criteria/measurement終點指標 Essential DocumentationExclusion Criteria 排 除 標 準Inclusion Criteria 入 選 表 準Gathering 信息收集Initial Meeting 啟動會議 Inspec

11、tion 構檢察Investigational Product 察員)必需文件Information檢察 / 視察InstitutionInspection 機試驗藥物 Investigator研究者 Monitor監(jiān)查員 （ 監(jiān)Monitoring 監(jiān)查 ( 監(jiān)察 ) Monitoring Plan監(jiān)查計劃（ 監(jiān)察計劃 ）Monitoring Report Non-clinical Study Outcome Assessment 結果評價Placebo Control Protocol AmendmentsPlacebo 安慰劑 Protocol 試驗方案 Reference Produc

12、t 性Severity 嚴重程度 Study Audit 研究稽查 選Subject Enrollment Log監(jiān)查報告 ( 監(jiān)察報告 ) Multi-center Trial非臨床研究 Original Medical RecordPatient File病人檔案安慰劑對照 Preclinical Study多中心試驗原始醫(yī)療記錄Patient History病歷臨床前研究隨機參比制劑 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 試驗啟動會議 TrialSubject Identification Code List Subject Screening Log Test Product Master File 試驗總檔案受試者入受試者識 受試者篩選表 受試制劑 Wash-out 洗洗脫期 堿性磷酸酶 批準三盲 Wash-out Period ）近似致死劑量 丙氨酸氨基轉換酶 批準 AT

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

15、CTA)臨床試驗申請臨床試驗免責Clinical trial protocol (CTP)合同研究組織病例報告表病例記錄表Clinicaltrial exemption臨床試驗方案 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Electronic data processing (EDP)試者入選表Institution review board (IBR)分析( 統(tǒng)計學)計算機輔助試驗設計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機構審查委員會 Intention-to-treat (ITT)Interactive voice response system (IVRS)互動式語音應答系統(tǒng)I