臨床英語(yǔ)術(shù)語(yǔ)縮寫表

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術(shù)縮寫

臨床研究用術(shù)語(yǔ)縮寫英全稱中全稱reaction/不良反應(yīng)Event/不AccompaniedSiteVisit/同訪視

業(yè)務(wù)拓展生物統(tǒng)計(jì)

BusinessDevelopmentBiostatistics

Documents/控Agreement/保密Documents臨床研究文件Committee/中心負(fù)責(zé)協(xié)

ChangeOrderForm/

工作范圍變更申請(qǐng)表CMDM

’s/Operations/臨床監(jiān)查/運(yùn)營(yíng)Clinical臨研究監(jiān)查助理Response痊愈Coordinator/臨Form/病例Organization/合Documents/臨床研究文件Report/臨床研Agreement/臨床Application/臨床試驗(yàn)申請(qǐng)Supplies/臨床試驗(yàn)用品Exemption/臨Vitae/履歷/數(shù)據(jù)澄清表DCF)/數(shù)andDCF)/數(shù)據(jù)澄清和解Management/數(shù)據(jù)管理Plan/數(shù)據(jù)管理計(jì)劃.

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術(shù)縮寫GMPMOHMW

英全稱中全稱Source//倫理委Form/電Capture/電子數(shù)據(jù)Study/研究結(jié)Union/Administration/美國(guó)食品藥品管理局Form/批準(zhǔn)的GoodPractice/臨床試驗(yàn)質(zhì)量管理規(guī)范Good/實(shí)驗(yàn)室質(zhì)量管理規(guī)范GoodPractice/藥GoodPractice/科學(xué)研發(fā)GoodPractice/統(tǒng)計(jì)質(zhì)量管理規(guī)范ofBrochure/IC)/知情同意書onHarmonization/國(guó)際協(xié)onGood/試驗(yàn)藥物手冊(cè)Committee/獨(dú)立倫理委員會(huì)FDA)/研究用Events/立treat/意向Agreement/研究者合同直線經(jīng)理ofIntent/意向書Health/衛(wèi)Agreement/MaximumDose/Writing/醫(yī)Available/不Entity/新Significant/無臨Done/未做

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術(shù)縮寫RMSOWUADR

英全稱中全稱Application./新藥上市申請(qǐng)其他文Procedure/OfScope/Survival/總體生存期Lead/Deviation/方案偏離/主要研究者Number/個(gè)人確認(rèn)密碼Manager/項(xiàng)經(jīng)理File/項(xiàng)Inspection/定期維護(hù)檢Surveillance/Plan/符Recruitment/Assurance/質(zhì)量管理Control/質(zhì)量控制Authorities/監(jiān)Monitoring/程監(jiān)查Monitoring/現(xiàn)場(chǎng)監(jiān)查=Monitoring/目化監(jiān)查/嚴(yán)Coordinator/研Visit/中心關(guān)閉訪視中Report/中Data/源Verification/原始數(shù)據(jù)核查Administration/國(guó)家食品藥品監(jiān)督管理局Code/受試者識(shí)別代碼Form/Visit/中心啟Procedure/標(biāo)Work/工次要研試驗(yàn)Reaction/非預(yù)期藥物不良反應(yīng)

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術(shù)縮寫WI

英全稱中全稱effect/非預(yù)期非Instruction/工作指南SOP類型縮寫表OP操作規(guī)程WI工作指南

OperatingProceduresWorkInstructionsTP模板

TemplateFM批準(zhǔn)的標(biāo)準(zhǔn)表格

ApprovedStandardFormsOD其他文件

OtherDocuments業(yè)務(wù)部門縮寫表/FunctionalAreaAbbreviationTable:BS生物統(tǒng)計(jì)

BiostatisticsBD業(yè)務(wù)拓展

BusinessDevelopmentCM臨床監(jiān)查/運(yùn)營(yíng)

ClinicalMonitoring/OperationDM數(shù)據(jù)管理

DataManagementIT信息技術(shù)

InformationTechnologyMS醫(yī)學(xué)科學(xué)服務(wù)

MedicalScienceServicePM項(xiàng)目管理QA質(zhì)量保證RM記錄管理

ProjectManagementQualityAssuranceRecordsManagementRA注冊(cè)事務(wù)

RegulatoryAffairsSMSOP管理

SOPManagementST研究中心管理服SiteServiceTR培訓(xùn)

Training：（TMF）TrialMasterFilePMF項(xiàng)目管理文件夾

ProjectManagementFileCCF申辦方臨床研究文件夾

CentralClinicalFileCIF申辦方-研究者文件夾

CentralInvestigatorF