臨床專業(yè)術(shù)語縮寫

1、術(shù)語縮寫英語全稱中文全稱ADE Adverse Drug Event藥物不良事件ADR Adverse Drug Reaction藥物副作用AE Adverse Event不良事件AI Assistant Investigator助理研究員BMI Body Mass索引體重金志洙CI Co-investigator合作研究人員COI Coordinating Investigator曹征研究人員CRA Clinical Research Associate林爽審計(jì)員(林爽監(jiān)察員)CRC Clinical Research Coordinator臨床研究協(xié)調(diào)員CRF Case Report Fo

2、rm病歷報(bào)告西餐cro contract research organization合同研究組織CSA Clinical Study Application臨床研究請求CTA Clinical Trial Application臨床試驗(yàn)請求CTX Clinical Trial Exemption臨床試驗(yàn)免責(zé)聲明CTP Clinical Trial Protocol臨床試驗(yàn)方案CTR Clinical Trial Report臨床試驗(yàn)報(bào)告Dsmb數(shù)據(jù)安全和監(jiān)視板數(shù)據(jù)安全和監(jiān)視委員會EDC Electronic Data Capture電子數(shù)據(jù)采集系統(tǒng)EDP電子數(shù)據(jù)處理電子數(shù)據(jù)處理系統(tǒng)FDA Fo

3、od and Drug Administration美國食品藥品監(jiān)督管理局FR Final Report摘要報(bào)告GCP好的臨床實(shí)踐藥物臨床試驗(yàn)品質(zhì)管制規(guī)范GLP好實(shí)驗(yàn)室實(shí)踐藥物鄭智薰臨床試驗(yàn)品質(zhì)管制規(guī)范GMP好制造實(shí)踐藥品生產(chǎn)品質(zhì)管制規(guī)范。IB Investigators Brochure研究人員手冊IC Informed Consent知情同意ICF信息內(nèi)容論壇知情同意書籍。ich international conference on harmonization國際曹征會議監(jiān)視IDM獨(dú)立數(shù)據(jù)監(jiān)視獨(dú)立數(shù)據(jù)(IDM Independent Data Monitoring Independent

4、 Data Monitoring)Idmc獨(dú)立數(shù)據(jù)監(jiān)控委員會獨(dú)立數(shù)據(jù)監(jiān)控委員會。IEC Independent Ethics Committee獨(dú)立倫理委員會IND Investigational New Drug新藥臨床研究IRB Institutional Review Board機(jī)構(gòu)審查委員會Ivd in vitro診斷in vitro診斷ivrs interactive voice response system交互式語音響應(yīng)系統(tǒng)ma marketing approval/authorization發(fā)布許可證MCA Medicines Control Agency英國藥品監(jiān)督管理局MH

5、W 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)物質(zhì)NIH National Institutes of Health National Health Institutes(美國國家衛(wèi)生研究所)PI Principal Investigator主要研究人員Pl產(chǎn)品許可產(chǎn)品許可Pma pre-market approval(應(yīng)用程序)預(yù)發(fā)布許可證(請求)psi statisticians in the pharmaceutical industry制藥產(chǎn)業(yè)統(tǒng)計(jì)學(xué)家協(xié)會

6、QA Quality Assurance質(zhì)量保證QC Quality Control品質(zhì)管制管理RA Regulatory Authorities教練SA Site Assessment現(xiàn)場評估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)重副作用SD Source Data/Document遠(yuǎn)視數(shù)據(jù)/檔案SD Subject Diary被實(shí)驗(yàn)者日記SFDA state food and drug administration國家食品藥品監(jiān)督管理局批準(zhǔn)

7、SDV Source Data Verification遠(yuǎn)視數(shù)據(jù)SEL Subject Enrollment Log被實(shí)驗(yàn)者選擇西餐SI Sub-investigator輔助研究員SI Sponsor-Investigator吸引研究人員SIC Subject Identification Code被實(shí)驗(yàn)者識別代碼SOP標(biāo)準(zhǔn)操作流程標(biāo)準(zhǔn)操作程序。SPL Study Personnel List研究人員列表SSL Subject Screening Log被實(shí)驗(yàn)者過濾器表TR Test and Reference Product persistence and Reference Product

8、(TR測試和參考產(chǎn)品測試和比較試劑)UAE Unexpected Adverse Event意外壞事件WHO World Health Organization世界衛(wèi)生組織who-ICD ra who international conference of drug regulatory authorities who國際藥物管理局會議主動控制陽性控制，主動控制稽核稽核審核報(bào)告審核報(bào)告。監(jiān)查院Blank Control空格控件Blinding/masking百葉簾/百葉簾Case History病歷Clinical study臨床研究Clinical Trial臨床試驗(yàn)Clinical Tri

9、al Report臨床試驗(yàn)報(bào)告法規(guī)遵從性合規(guī)性Coordinating Committee協(xié)調(diào)委員會Cross-over Study cross research(跨工作室交叉研究)雙綁定雙盲法。端點(diǎn)Criteria/measurement結(jié)束指示器Essential Documentation必要檔案Exclusion Criteria排除標(biāo)準(zhǔn)Inclusion Criteria選擇標(biāo)準(zhǔn)收集信息聚合信息。啟動Initial Meeting牙齒會議Inspection檢察/視察Institution Inspection機(jī)關(guān)檢察機(jī)關(guān)Investigational Product實(shí)驗(yàn)藥Inves

10、tigator研究人員顯示器審計(jì)員(監(jiān)察員)監(jiān)視審計(jì)(監(jiān)視)監(jiān)控計(jì)劃監(jiān)控計(jì)劃(監(jiān)控計(jì)劃)監(jiān)視報(bào)告審計(jì)報(bào)告(監(jiān)視報(bào)告)Multi-center Trial Multi-center Trial Multi-center test(多中心軌跡多中心測試)非clinical Study鄭智薰臨床研究原始醫(yī)學(xué)記錄遠(yuǎn)視醫(yī)療記錄。評估Outcome Assessment結(jié)果Patient File患者檔案Patient History病歷Placebo安慰劑Placebo Control安慰劑控制Preclinical Study林爽前研究Protocol試驗(yàn)節(jié)目Protocol Amendments修訂隨機(jī)隨機(jī)RandomizationReference Product比較劑范例大小范例大小，范例大小Seriousness嚴(yán)重度嚴(yán)重性嚴(yán)重度級別單混合單百葉簾斯潘塞Study審核研究Subject被實(shí)驗(yàn)者Subject Enrollment被實(shí)驗(yàn)者選擇Subject Enrollment Log被實(shí)驗(yàn)者選擇西餐Subject Identification Code List受試者識別代碼表招聘Subject Recruitment被實(shí)驗(yàn)