臨床試驗常用的英文縮寫

1、貝腳內(nèi)容專業(yè)術(shù)語中文全稱縮略語英文全稱DCFdataclarificationform數(shù)據(jù)澄清表，用于紙質(zhì)querySDVsourcedataverification原始數(shù)據(jù)核對ADEAdverseDrugEvent藥物不良事件ADRAdverseDrugReaction藥物不良反應AEAdverseEvent不良事件Al Assistant Investigator助理研究者BMIBodyMassIndex體質(zhì)指數(shù)CICo-investigator合作研究者協(xié)調(diào)研究者COICoordinatingInvestigatorCRAClinicalResearchAssociateCRCClini

2、cal Research Coordinator臨床監(jiān)查員（臨床監(jiān)察員）CRFCase Report Form臨床研究協(xié)調(diào)者 病歷報告表CROContract Research Organization合同研究組織CSA Clinical Study Application臨床研究申請CTA Clinical Trial Application臨床試瞼申請CTXClinical Trial Exemption臨床試驗免責CTPClinical Trial Protocol臨床試驗方案CTRClinical Trial Report臨床試瞼報告電子數(shù)據(jù)采集系統(tǒng)DSMBDataSafetyandm

3、onitoringBoard數(shù)據(jù)安全及監(jiān)控委員會EDCElectronicDataCapture電子數(shù)拯處理系統(tǒng)EDPElectronicDataProcessingFDAFoodandDnigAdministration美國食品與藥品管理局FRFinalReportGCPGoodClinicalPracticeGLPGoodLaboratoryPracticeGMPGoodManufacturingPracticeIBInvestigator'sBrochureICInformedConsentICFInformedConsentFormICHInternationalConfere

4、nceon總結(jié)報告藥物臨床試驗質(zhì)量管理規(guī)范藥物非臨床試驗質(zhì)量管理規(guī)范藥品生產(chǎn)質(zhì)量管理規(guī)范研究者手冊知情同意知情同意書Harmonization國際協(xié)調(diào)會議IDMIndependentDataMonitoring獨立數(shù)據(jù)監(jiān)察IDMCIndependentDataMonitoringCommittee獨立數(shù)據(jù)監(jiān)察委員會IECIndependentEthicsCommittee獨立倫理委員會INDInvestigationalNewDrug新藥臨床研究IRBInstitutionalReviewBoard機構(gòu)審查委員會IVDInVitroDiagnostic體外診斷IVRSInteractiveVo

5、iceResponseSystem互動語苜應答系統(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NDA New Drug ApplicationNEC New Drug EntityNIH National Institutes of HealthPI Principal InvestigatorPL Product License新藥申請新化學實體1 國家衛(wèi)生研究所（美國）主要研究者產(chǎn)品許可證PMAPre-marketAppr

6、oval(Application)上市前許可申in)PSIStatisticiansinthePharmaceuticalIndustry制藥業(yè)統(tǒng)計學家協(xié)會QAQualityAssuranceQCQualityControlRARegulatoryAuthoritiesSASiteAssessmentSAESeriousAdverseEvent質(zhì)量保證質(zhì)量控制監(jiān)督管理部門現(xiàn)場評估嚴重不良事件SAPStatisticalAnalysisPlan統(tǒng)計分析計劃SARSeriousAdverseReaction嚴重不良反應SDSourceData/Document原始數(shù)據(jù)/文件SDSubjectDia

7、ry受試者日記原始數(shù)據(jù)核準受試者入選表助理研究者SFDAStateFoodandDrugAdministration國家食品藥品監(jiān)督管理局SDVSourceDataVerificationSELSubjectEnrollmentLogSISub-investigatorSISponsor-Investigator申辦研究者SICSubjectIdentificationCode受試者識別代碼SOPSPLStudy Personnel List研究人員名單SSLSubject Screening Log受試者篩選表T&RTest and Reference Product受試和參比試劑S

8、tandardOperatingProcedure標準操作規(guī)程預料外不良事件世界衛(wèi)生組織UAEUnexpectedAdverseEventWHOWorldHealthOrganizationWHO-ICDRAWHOInternationalConferenceofDrugRegulatoryAuthoritiesWHO國際藥品管理當局會議ActiveControlAuditAuditReportAuditorBlankControl陽性對照、活性對照稽查稽查報告稽查員空白對照Blinding/maskingCaseHistoryClinicalstudyClinicalTrialClinica

9、lTrialReportComplianceCoordinatingCommitteeCross-overStudyDoubleBlindingEndpointCriteria/measurementEssentialDocumentationExclusionCriteriaInclusionCriteriaInformationGatheringInitialMeetingInspectionInstitutionInspectionInvestigationalProductInvestigatorMonitorMonitoringMonitoringPlanMonitoringRepo

10、rtMulti-centerTrialNon-clinicalStudyOriginalMedicalRecordOutcomeAssessmentPatientFilePatientHistoryPlaceboPlaceboControlPreclinicalStudyProtocolProtocolAmendmentsRandomizationReferenceProductSampleSizeSeriousness盲法/設(shè)盲病歷臨床研究臨床試驗臨床試驗報告依從性協(xié)調(diào)委員會交叉研究雙盲終點指標必需文件排除標準入選表準信息收集啟動會議檢察/視察機構(gòu)檢察試驗藥物研究者監(jiān)查員（監(jiān)察員）監(jiān)查（監(jiān)察）監(jiān)查計劃（監(jiān)察計劃）監(jiān)查報告（監(jiān)察報告）多中心試驗非臨床研究原始醫(yī)療記錄結(jié)果評價病人檔案病歷安慰劑安慰劑對照臨床前研究試驗方案修正案隨機參比制劑樣本量、樣本大小嚴重性jiw內(nèi)客 貝腳內(nèi)容Severity嚴重程度單盲申辦者SingleBlindingSponsorStudyAuditSubjectSubjectEnrollmentSubjectEnrollmentLog研究稽查受試者受試者入選SubjectIdentificationCodeList受優(yōu)善識別祀碼表SubjectRecniitmentStudySit