臨床試驗(yàn)常用的英文縮寫-文庫吧
2025-04-09 22:05 本頁面
【正文】 nformed Consent 知情同意ICF Informed Consent Form 知情同意書ICH International Conference on Harmonization國際協(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(qǐng)NEC New Drug Entity 新化學(xué)實(shí)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(chǎn)品許可證PMA Premarket 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S
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