臨床試驗(yàn)常用術(shù)語(yǔ)解釋說(shuō)明-展示頁(yè)
2025-01-26 22:45本頁(yè)面
【正文】 tor 監(jiān)查員SAE 嚴(yán)重不良事件SDV 原始資料核對(duì)SFDA 國(guó)家食品藥品監(jiān)督管理局SOP 標(biāo)準(zhǔn)操作規(guī)程ULN 正常參考值上限WHO 世界衛(wèi)生組織Active control ,AC 陽(yáng)性對(duì)照，活性對(duì)照 陽(yáng)性對(duì)照，活性對(duì)照Adverse drug reaction ,ADR 藥物不良反應(yīng) 藥物不良反應(yīng)Adverse event ,AE 不良事件Approval 批準(zhǔn)Assistant investigator 助理研究者Audit 稽查Audit report 稽查報(bào)告Auditor 稽查員Bias 偏性，偏倚Blank control 空白對(duì)照Blinding/masking 盲法，設(shè)盲Block 層Case history 病歷Case report form/case record form ,CRF 病例報(bào)告表，病例記錄表Clinical study 臨床研究Clinical trial 臨床試驗(yàn)Clinical trial application ,CTA 臨床試驗(yàn)申請(qǐng)Clinical trial exemption ,CTX 臨床試驗(yàn)免責(zé)Clinical trial protocol ,CTP 臨床試驗(yàn)方案Clinical trial/study report 臨床試驗(yàn)報(bào)告Coinvestigator 合作研究者Comparison 對(duì)照Compliance 依從性Computerassisted trial design ,CATD 計(jì)算機(jī)輔助試驗(yàn)設(shè)計(jì)Contract research organization ,CRO 合同研究組織Contract/agreement 協(xié)議 / 合同Coordinating mittee 協(xié)調(diào)委員會(huì)Coordinating investigator 協(xié)調(diào)研究者Crossover study 交叉研究Cure 痊愈Documentation 記錄/ 文件Dosereaction relation 劑量—反應(yīng)關(guān)系Double blinding 雙盲Double dummy technique 雙盲雙模擬技術(shù)Electronic data capture ,EDC 電子數(shù)據(jù)采集系統(tǒng)Electronic data processing ,EDP 電子數(shù)據(jù)處理系統(tǒng)Endpoint criteria/measurement 終點(diǎn)指標(biāo)Essential documentation 必需文件Excellent 顯效Exclusion criteria 排除標(biāo)準(zhǔn)Failure 無(wú)效，失敗Final report 總結(jié)報(bào)告Final point 終點(diǎn)Forced titration 強(qiáng)制滴定Generic drug 通用名藥Good clinical practice ,GCP 藥物臨床試驗(yàn)質(zhì)量管理規(guī)定Good manufacture practice ,GMP 藥品生產(chǎn)質(zhì)量管理規(guī)范Good nonclinical laboratory practice ,GLP 藥物非臨床研究質(zhì)量管理規(guī)范Health economic evaluation ,HEV 健康經(jīng)濟(jì)學(xué)評(píng)價(jià)Hypothesis testing 假設(shè)檢驗(yàn)Improvement 好轉(zhuǎn)Inclusion criteria 入選標(biāo)準(zhǔn)Independent ethics mittee ,IEE 獨(dú)立倫理委員會(huì)Information gathering 信息收集Informed consent form ,ICF 知情同意書Informed consent ,IC 知情同意Initial meeting 啟動(dòng)會(huì)議Inspection 視察/ 檢查Institution inspection 機(jī)構(gòu)檢查Institutional review board ,IBR 機(jī)構(gòu)審查委員會(huì)Intention to treat 意向治療Interactive voice response system ,IVRS 互動(dòng)式語(yǔ)音應(yīng)答系統(tǒng)International Conference on Harmonization ,ICH 國(guó)際協(xié)調(diào)會(huì)議Investigational new drug ,IND 新藥臨床研究Investigational product 試驗(yàn)藥物Investigator 研究者Investigator ’ s brochure ,I B 研究者手冊(cè)Marketing approval/authorization 上市許可證Matched pair 匹配配對(duì)Monitor 監(jiān)查員Monitoring 監(jiān)查Monitoring report 監(jiān)查報(bào)告Multicenter trial 多中心試驗(yàn)New chemical entity ,NCE 新化學(xué)實(shí)體New drug application ,NDA 新藥申請(qǐng)Nonclinical study 非臨床研究Obedience 依從性O(shè)ptional titration 隨意滴定Original medical record 原始醫(yī)療記錄Oute 結(jié)果Oute assessment 結(jié)果指標(biāo)評(píng)價(jià)Oute measurement 結(jié)果指標(biāo)Patient file 病人指標(biāo)Patient history 病歷Placebo 安慰劑Placebo control 安慰劑對(duì)照Preclinical study 臨床前研究Principle investigator ,PI 主要研究者Product license ,PL 產(chǎn)品許可證Protocol 試驗(yàn)方案Protocol amendment 方案補(bǔ)正Quality assurance ,QA 質(zhì)量保證Quality assurance unit ,QAU 質(zhì)量保證部門Quality control ,QC 質(zhì)量控制Randomization 隨機(jī)egulatory authorities ,RA 監(jiān)督管理部門Replication 可重復(fù)Run in 準(zhǔn)備期Sample size 樣本量，樣本大小Serious adverse event ,SAE 嚴(yán)重不良事件Serious adverse reaction ,SAR 嚴(yán)重不良反應(yīng)Seriousness 嚴(yán)重性Severity 嚴(yán)重程度Simple randomization 簡(jiǎn)單隨機(jī)Single blinding 單盲Site audit 試驗(yàn)機(jī)構(gòu)稽查Source
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