-臨床英語(yǔ)術(shù)語(yǔ)縮寫表

1、編號(hào)術(shù)語(yǔ)縮寫adraeasv臨床研究常用術(shù)語(yǔ)縮寫表 英文全稱/中文全稱adverse drug reaction/不良反應(yīng) adverse event/不良事件 accompanied site visit/陪同訪視bdbs業(yè)務(wù)拓展生物統(tǒng)計(jì)business developmentbiostatisticsccfcdcdacdccsdscecco-icentral clinical file申辦方臨床研究文件夾controlled documents/控制文件confidentiality disclosure agreement/保密協(xié)議center for disease control/疾

2、病控制中心clinical study documents臨床研究文件central ethics committee/中心倫理委員會(huì)coordinating investigator負(fù)責(zé)協(xié)調(diào)不同中心參加多中心臨床試驗(yàn) 研究者的研究者cofchange order form/工作范圍變更申請(qǐng)表cifcmcmacrcracrccrfcrocsdscsrctactactactsctxcvdcfdcrdcrfdmdmpcentral investigators申file辦者研究者文件夾（中心研究者文件夾）clinical monitoring / operations/臨床監(jiān)查/運(yùn)營(yíng)clinical

3、 monitoring associate/臨床研究監(jiān)查助理complete response痊愈clinical research associate (equivalent to clinical study monitor) 臨床監(jiān)查員clinical research coordinator/臨床研究協(xié)調(diào)員case report form or case record form/病例報(bào)告表contract research organization/合同研究組織clinical study documents/臨床研究文件clinical study report/臨床研究報(bào)告clin

4、ical trial assistant (equivalent to clinical research assistant) 臨床研究助理clinical trial agreement/臨床試驗(yàn)協(xié)議clinical trial application/臨床試驗(yàn)申請(qǐng)clinical trial supplies/臨床試驗(yàn)用品clinical trial exemption/臨床試驗(yàn)免責(zé)c urriculum vitae/履歷d ata clarification form數(shù)據(jù)/澄清表data clarification report (see dcf)/數(shù)據(jù)澄清報(bào)告data clarifi

5、cation and resolution form (see dcf)/數(shù)據(jù)澄清和解決表data management/ 數(shù)據(jù)管理data management plan/ 數(shù)據(jù)管理計(jì)劃書編號(hào)術(shù)語(yǔ)縮寫dqfddeeecrfedceoseufasfdafmgcpglpgmpgrpggghhhibicicfichich-gcpidbiecindipiraesirbittisaisflmlllmmmmsamtdmmnnncencsnd英文全稱/中文全稱data query form/數(shù)據(jù)疑問表d ata source/數(shù)據(jù)源e thics committee 倫/理委員會(huì)electronic ca

6、se report form/電子病歷報(bào)告表electronic data capture/電子數(shù)據(jù)采集end of study/研究結(jié)束e uropean union/歐盟f ull analysis set/全分析集food and drug administration/美國(guó)食品藥品管理局approved standard form/批準(zhǔn)的標(biāo)準(zhǔn)表格good clinical practice/臨床試驗(yàn)質(zhì)量管理規(guī)范good laboratory practice實(shí)/驗(yàn)室質(zhì)量管理規(guī)范good manufacturing practice/藥品生產(chǎn)質(zhì)量管理規(guī)范good research pra

7、ctice/科學(xué)研發(fā)質(zhì)量管理規(guī)范g ood statistical practice/統(tǒng)計(jì)質(zhì)量管理規(guī)范h ead of clinical operations臨床運(yùn)營(yíng)總監(jiān)i nvestigators brochure/研究者手冊(cè)informed consent/ 知情同意informed consent form (also see ic)/知情同意書international conference on harmonization/國(guó)際協(xié)調(diào)會(huì)議 international conference on harmonisation tripartite guideline on good cli

8、nical practice國(guó)際協(xié)調(diào)會(huì)議藥品臨床試驗(yàn)質(zhì)量管理規(guī)范指南investigational drug brochure試驗(yàn)/藥物手冊(cè)independent ethic committee/獨(dú)立倫理委員會(huì)investigational new drug (us fda)/研究用新藥investigational product/研究用產(chǎn)品immediately reportable adverse events/立即上報(bào)的不良事件 institutional review board.機(jī)構(gòu)/審查委員會(huì)intention to treat/意向性治療investigator study a

9、greement/研究者合同investigational site file研究者文件夾line manager/直線經(jīng)理l etter of intent/意向書m inistry of health/衛(wèi)生部master services agreement/主服務(wù)協(xié)議maximum tolerated dose/ 最大耐受劑量m edical writing/醫(yī)學(xué)寫作n ot available/不可用new chemical entity/新化學(xué)實(shí)體not clinically significant/無(wú)臨床意義not done/未做編號(hào)術(shù)語(yǔ)縮寫ndaodopoososotlpdpip

10、inpkpmpmfpmipmsppppppqqqqrrrmsaescscvssvsmvsvrsdsdvsfdasicsifsivsopsowsub-isusartptmfuadr英文全稱/中文全稱n ew drug application./新藥上市申請(qǐng)o ther documents/ 其他文件operating procedure/操作規(guī)程out of scope/超工作范圍overall survival/總體生存期o perational team lead/運(yùn)營(yíng)團(tuán)隊(duì)負(fù)責(zé)人p rotocol deviation/方案偏離principle investigator /主要研究者pers

11、onal identification number/個(gè)人確認(rèn)密碼 pharmacokinetics/藥物代謝動(dòng)力學(xué)project manager/項(xiàng)目經(jīng)理project managerment file/項(xiàng)目管理文件夾periodic maintenance inspection/定期維護(hù)檢查 post-marketing surveillance/上市后藥物檢測(cè)project plan/項(xiàng)目計(jì)劃per protocol/符合方案集p atient recruitment/ 患者招募q uality assurance/質(zhì)量管理q uality control/質(zhì)量控制r egulatory

12、 authorities/監(jiān)督管理部門remote monitoring/遠(yuǎn)程監(jiān)查on-site monitoring/現(xiàn)場(chǎng)監(jiān)查=on-target monitoring/目標(biāo)化監(jiān)查 serious adverse event /嚴(yán)重不良事件study coordinator/研究協(xié)調(diào)員site close-out visit/中心關(guān)閉訪視site selection visit/中心篩選訪視site monitoring visit/中心監(jiān)查訪視site visit report/中心訪視報(bào)告source data/源數(shù)據(jù)source data verification/原始數(shù)據(jù)核查stat

13、e food and drug administration/國(guó)家食品藥品監(jiān)督管理局 subject identification code/受試者識(shí)別代碼site information form/中心信息表site initiation visit/中心啟動(dòng)訪視standard operating procedure/標(biāo)準(zhǔn)操作規(guī)程scope of work/工作范圍subinvestigator次要研究者suspected unexpected serious adverse reaction可疑的非預(yù)期的嚴(yán)重不良反應(yīng)template/模版t rial master file/試驗(yàn)主文檔u

14、 nexpected adverse drug reaction/非預(yù)期藥物不良反應(yīng)編號(hào)術(shù)語(yǔ)縮寫uadeuaewi英文全稱/中文全稱unanticipated adverse drug effect/非預(yù)期的不良反應(yīng) unexpected adverse event/非預(yù)期的不良事件work instruction/工作指南sop 類型縮寫表op 操作規(guī)程 wi 工作指南operating procedureswork instructionstp 模板templatefm 批準(zhǔn)的標(biāo)準(zhǔn)表格approved standard formsod 其他文件other documents業(yè)務(wù)部門縮寫表/

15、 functional area abbreviation table:bs 生物統(tǒng)計(jì)biostatisticsbd 業(yè)務(wù)拓展business developmentcm 臨床監(jiān)查/運(yùn)營(yíng)clinical monitoring/operationdm 數(shù)據(jù)管理data managementit 信息技術(shù)information technologyms 醫(yī)學(xué)科學(xué)服務(wù)medical science servicepm 項(xiàng)目管理 qa 質(zhì)量保證 rm 記錄管理p roject managementq uality assurancer ecords managementra 注冊(cè)事務(wù)regulatory affairssm sop 管理sop managementst 研究中心管理服務(wù)site management servicetr 培訓(xùn)training試驗(yàn)主文檔