臨床研究專業(yè)術(shù)語、縮略語中英對照表優(yōu)選

1、ActiveControl陽性對照、活性對照ADEAdverseDrugEvent藥物不良事件ADRAdverseDrugReaction藥物不良反應(yīng)AEAdverseEvent不良事件AIAssistantInvestigator助理研究者AuditReport稽查報告Audit稽查Auditor稽查員BlankControl空白對照Blinding/masking盲法/設(shè)盲BMIBodyMassIndex體質(zhì)指數(shù)CaseHistory病歷CICo-investigator合作研究者Clinicalstudy臨床研究ClinicalTrialReport臨床試驗報告ClinicalTrial

2、臨床試驗COICoordinatingInvestigator協(xié)調(diào)研究者Compliance依從性CoordinatingCommittee協(xié)調(diào)委員會CRCClinicalResearchCoordinator臨床研究協(xié)調(diào)者CRFCaseReportForm病歷報告表CROContractResearchOrganization合同研究組織Cross-overStudy交叉研究CSAClinicalStudyApplication臨床研究申請CTAClinicalTrialApplication臨床試驗申請CTPClinicalTrialProtocol臨床試驗方案CTRClinicalTri

3、alReport臨床試驗報告CTXClinicalTrialExemption臨床試驗免責(zé)DoubleBlinding雙盲DMP數(shù)據(jù)管理計劃DSMBDataSafetyandmonitoringBoard數(shù)據(jù)安全及監(jiān)控委員會DVP數(shù)據(jù)核查計劃eCRF電子病歷報告EDCElectronicDataCapture電子數(shù)據(jù)采集系統(tǒng)EDPElectronicDataProcessing電子數(shù)據(jù)處理系統(tǒng)EndpointCriteria終點(diǎn)指標(biāo)EssentialDocumentation必需文件ExclusionCriteria排除標(biāo)準(zhǔn)FDAFoodandDrugAdministration美國食品與藥品

4、管理局FRFinalReport總結(jié)報告GCPGoodClinicalPractice藥物臨床試驗質(zhì)量管理規(guī)范GCPGoodLaboratoryPractice藥物非臨床試驗質(zhì)量管理規(guī)范GMPGoodManufacturingPractice藥品生產(chǎn)質(zhì)量管理規(guī)范IBInvestigatorsBrochure研究者手冊ICInformedConsent知情同意ICFInformedConsentForm知情同意書ICHInternationalConferenceonHarmonization國際協(xié)調(diào)會議IDMIndependentDataMonitoring獨(dú)立數(shù)據(jù)監(jiān)察IDMCIndepend

5、entDataMonitoringCommittee獨(dú)立數(shù)據(jù)監(jiān)察委員會IECIndependentEthicsCommittee獨(dú)立倫理委員會InclusionCriteria入選表準(zhǔn)INDInvestigationalNewDrug新藥臨床研究InformationGathering信息收集InitialMeeting啟動會議Inspection檢察/視察InstitutionInspection機(jī)構(gòu)檢察InvestigationalProduct試驗藥物Investigator研究者IRBInstitutionalReviewBoard機(jī)構(gòu)審查委員會IVDInVitroDiagnostic

6、體外診斷IVRSInteractiveVoiceResponseSystem互動語音應(yīng)答系統(tǒng)MAMarketingApproval/Authorization上市許可證MCAMedicinesControlAgency英國藥品監(jiān)督局MHWMinistryofHealthandWelfare日本衛(wèi)生福利部Monitor監(jiān)察員MonitoringPlan監(jiān)察計劃MonitoringReport監(jiān)察報告Monitoring監(jiān)察Multi-centerTrial多中心試驗NDANewDrugApplication新藥申請NECNewDrugEntity新化學(xué)實(shí)體NIHNationalInstitute

7、sofHealth國家衛(wèi)生研究所（美國）Non-clinicalStudy非臨床研究OriginalMedicalRecord原始醫(yī)療記錄OutcomeAssessment結(jié)果評價PatientFile病人檔案PatientHistory病歷PIPrincipalInvestigator主要研究者PLProductLicense產(chǎn)品許可證PlaceboControl安慰劑對照Placebo安慰劑PM項目經(jīng)理PMAPre-marketApproval(Application)上市前許可(申請)PMP項目組建立PreclinicalStudy臨床前研究ProtocolAmendments修正案Pr

8、otocol試驗方案PSIStatisticiansinthePharmaceuticalIndustry制藥業(yè)統(tǒng)計學(xué)家協(xié)會QAQualityAssurance質(zhì)量保證QCQualityControl質(zhì)量控制RARegulatoryAuthorities監(jiān)督管理部門Randomization隨機(jī)ReferenceProduct參比制劑RegulatoryAuthoritiesSASiteAssessment現(xiàn)場評估SAESeriousAdverseEvent嚴(yán)重不良事件SampleSize樣本量、樣本大小SAPStatisticalAnalysisPlan統(tǒng)計分析計劃SARSeriousAdv

9、erseReaction嚴(yán)重不良反應(yīng)SDSourceData/Document原始數(shù)據(jù)/文件SDSubjectDiary受試者日記SDVSourceDataVerification原始數(shù)據(jù)核準(zhǔn)SELSubjectEnrollmentLog受試者入選表Seriousness嚴(yán)重性Severity嚴(yán)重程度SFDAStateFoodandDrugAdministration國家食品藥品監(jiān)督管理局SISponsor-Investigator申辦研究者SISub-investigator助理研究者SICSubjectIdentificationCode受試者識別代碼SimpleRandomization

10、樣本量、樣本大小SingleBlinding單盲SOPStandardOperatingProcedure標(biāo)準(zhǔn)操作規(guī)程SPLStudyPersonnelList研究人員名單Sponsor申辦者SSLSubjectScreeningLog受試者篩選表StudyAudit研究稽查StudySite研究中心SubjectEnrollmentLog受試者入選表SubjectEnrollment受試者入選SubjectIdentificationCodeList受試者識別代碼表SubjectRecruitment受試者招募SubjectScreeningLog受試者篩選表Subject受試者SystemAudit系統(tǒng)稽查T&RTestandReferenceProduct受試和參比試劑TestProduct受試制劑TrialInitialMeeting試驗啟動會議TrialMasterFile試驗總檔案TrialObjective試驗?zāi)康腡ripleBlinding三盲UAEUnexpectedAdverse