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D Subject Diary 受試者日記SFDA State Food and Drug Administration國(guó)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 Subinvestigator 助理研究者SI SponsorInvestigator 申辦研究者SIC Subject Identification Code 受試者識(shí)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Tamp。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WHOICDRA WHO International Conference of Drug Regulatory AuthoritiesWHO國(guó)際藥品管理當(dāng)局會(huì)議Active Control 陽(yáng)性對(duì)照、活性對(duì)照Audit 稽查Audit Report 稽查報(bào)告Auditor 稽查員Blank Control 空白對(duì)照Blinding/masking 盲法/設(shè)盲Case History 病歷Clinical study 臨床研究Clinical Trial 臨床試驗(yàn)Clinical Trial Report 臨床試驗(yàn)報(bào)告Compliance 依從性Coordinating Committee 協(xié)調(diào)委員會(huì)Crossover Study