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专业术语缩略语英文全称中文全称ADEAdverseDrugEvent药物不良__ADRAdverseDrugReaction药物不良反应AEAdverseEvent不良__AIAssistantInvestigator助理研究者BMIBodyMassIndex体质指数CICo-investigator合作研究者COICoordinatingInvestigator协调研究者CRAClinicalResearchAssociate临床监查员临床监察员CRCClinicalResearchCoordinator临床研究协调者CRFCaseReportForm病历报告表CROContractResearchOrganization合同研究组织ECRF电子化病历报告表CSAClinicalStudyApplication临床研究申请CTAClinicalTrialApplication临床试验申请CTXClinicalTrialExemption临床试验免责CTPClinicalTrialProtocol临床试验方案CTRClinicalTrialReport临床试验报告D__BDataSafetyandmonitoringBoard数据安全及监控委员会EDCElectronicDataCapture电子数据采集系统EDPElectronicDataPro__ssing电子数据处理系统FDAFoodandDrugAdministration美国食品与药品管理局FRFinalReport总结报告GCPGoodClinicalPracti__药物临床试验质量管理规范GLPGoodLaboratoryPracti__药物非临床试验质量管理规GMPGoodManufacturingPracti__药品生产质量管理规范IBInvestigator’sBrochure研究者手册ICInformedConsent知情同意ICFInformedConsentForm知情同意书ECGElectrocardiogram心电图ICHInternationalConferen__onHarmonization国际协调会IDMIndependentDataMonitoring__数据监察IDMCIndependentDataMonitoringCommittee__数据监察委员会IECIndependentEthicsCommittee__伦理委员会INDInvestigationalNewDrug新药临床研究IRBInstitutionalReviewBoard机构审查委员会IVDInVitroDiagnostic体外诊断MAMarketingApproval/Authorization上市许可证IVRSInteractiveVoi__ResponseSystem互动__应答系统MCAMedicinesControlAgency英国药品监督局MHWMinistryofHealthandWelfare__卫生福利部NDANewDrugApplication新药申请NECNewDrugEntity新化学实体NIHNationalInstitutesofHealth国家卫生研究所美国PIPrincipalInvestigator主要研究者PLProductLi__nse产品许可证PMAPre-__rketApprovalApplication上市前许可申请PSIStatisticiansinthePhar____uticalIndustry制药业统计学家协会QAQualityAssuran__质量保证QCQualityControl质量控制RARegulatoryAuthorities监督管理部门SASiteAsses__ent现场评估SAESeriousAdverseEvent严重不良__SAPStatisticalAnalysisPlan统计分析计划SARSeriousAdverseReaction严重不良反应SDSour__Data/Document原始数据/文件SDSubjectDiary受试者日记SubjectidentificationcodeSIC受试者识别代码SFDAStateFoodandDrugAdministration国家食品药品监督管理局SDVSour__DataVerification原始数据核准SELSubjectEnrollmentLog受试者入选表SISub-investigator助理研究者SISponsor-Investigator申办研究者SICSubjectIdentificationCode受试者识别代码pdphar__codynamics药物效应动力学SOPStandardOperatingPro__dure标准操作规程pkphar__cokinetics药物代谢动力学SPLStudyPersonnelList研究人员__SSLSubjectScreeningLog受试者筛选表TRTestandReferen__Product受试和参比试剂UAEUnexpectedAdverseEvent预料外不良__WHOWorldHealthOrganization世界卫生组织ActiveControl阳性对照、活性对照WHO-ICDRAWHOInternationalConferen__ofDrugRegulatoryAuthoritiesWHO国际药品管理当局会议UnexpectedadverseeventUAE预料外不良__Audit稽查AuditReport稽查报告Auditor稽查员BlankControl空白对照Blinding/__sking盲法/设盲CaseHistory病历Clinicalstudy临床研究ClinicalTrial临床试验ClinicalTrialReport临床试验报告Complian__依从性CoordinatingCommittee协调委员会Cross-overStudy交叉研究DoubleBlinding双盲EndpointCriteria/measurement终点指标EssentialDocumentation必需文件ExclusionCriteria排除标准InclusionCriteria入选表准Infor__tionGathering信息收集InitialMeeting启动会议Inspection检察/视察InstitutionInspection机构检察InvestigationalProduct试验药物Investigator研究者Monitor监查员监察员Monitoring监查监察MonitoringPlan监查计划监察计划MonitoringReport监查报告监察报告Multi-__nterTrial多中心试验Non-clinicalStudy非临床研究OriginalMedicalRecord原始医疗记录OutcomeAsses__ent结果评价PatientFile病人档案PatientHistory病历Pla__bo安慰剂Pla__boControl安慰剂对照PreclinicalStudy临床前研究Protocol试验方案ProtocolAmendments修正案Randomization随机Referen__Product参比制剂SampleSize样本量、样本大小Seriousness严重性Severity严重程度SingleBlinding单盲Sponsor申办者StudyAudit研究稽查Subject受试者SubjectEnrollment受试者入选SubjectEnrollmentLog受试者入选表SubjectIdentificationCodeList受试者识别代码表SubjectRecruitment受试者招募SubjectScreeningLog受试者筛选表SystemAudit系统稽查StudySite研究中心TestProduct受试制剂TrialInitialMeeting试验启动会议TrialMasterFile试验总档案Wash-out洗脱TrialObjective试验目的TripleBlinding三盲Wash-outPeriod洗脱期Alb白蛋白ALD(Approxi__teLethalDose)近似致死剂量ALP碱性磷酸酶Alphaspendingfunction消耗函数ALT丙氨酸氨基转换酶Approval批准Analysissets统计分析的数据集Approval批准ATR衰减全反射法Assistantinvestigator助理研究者AST天门冬酸氨基转换酶AUCss稳态血药浓度-时间曲线下__Standardoperatingpro__dureSOP标准操作规程Casereportform/caserecordformCRF病例报告表病例记录表ClinicaltrialapplicationCTA临床试验申请ClinicaltrialexemptionCTX临床试验免责ClinicaltrialprotocolCTP临床试验方案ContractresearchorganizationCRO合同研究组织Computer-assistedtrialdesignCATD计算机辅助试验设计Sour__dataSD原始数据ElectronicdatacaptureEDC电子数据采集系统Sour__dataverificationSDV原始数据核准Electronicdatapro__ssingEDP电子数据处理系统Subjectenrollmentlog受试者入选表InstitutionreviewboardIBR机构审查委员会Intention-to–treatITT意向性分析-统计学)Interactivevoi__responsesystemIVRS互动式__应答系统Investigator’sbrochureIB研究者手册MaximumToleratedDoseMTD最大耐受剂量PrincipleinvestigatorPI主要研究者Productli__nsePL产品许可证SeriousadverseeventSAE严重不良__SeriousadversereactionSAR严重不良反应。