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专业术语缩略语英文全称中文全称ADEAdverseDrugEvent药物不良事件ADRAdverseDrugReaction药物不良反应AEAdverseEvent不良事件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DSMBDataSafetyandmonitoringBoard数据安全及监控委员会EDCElectronicDataCapture电子数据采集系统EDPElectronicDataProcessing电子数据处理系统FDAFoodandDrugAdministration美国食品与药品管理局FRFinalReport总结报告GCPGoodClinicalPractice药物临床试验质量管理规范GLPGoodLaboratoryPractice药物非临床试验质量管理规GMPGoodManufacturingPractice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ICHInternationalConferenceonHarmonization国际协调会IDMIndependentDataMonitoring独立数据监察IDMCIndependentDataMonitoringCommittee独立数据监察委员会IECIndependentEthicsCommittee独立伦理委员会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IVRSInteractiveVoiceResponseSystem互动语音应答系统MCAMedicinesControlAgency英国药品监督局MHWMinistryofHealthandWelfare日本卫生福利部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PLProductLicense产品许可证PMAPre-marketApproval(Application)上市前许可(申请)PSIStatisticiansinthePharmaceuticalIndustry制药业统计学家协会QAQualityAssurance质量保证QCQualityControl质量控制RARegulatoryAuthorities监督管理部门SASiteAssessment现场评估SAESeriousAdverseEvent严重不良事件SAPStatisticalAnalysisPlan统计分析计划SARSeriousAdverseReaction严重不良反应SDSourceData/Document原始数据/文件SDSubjectDiary受试者日记Subjectidentificationcode(SIC)受试者识别代码SFDAStateFoodandDrugAdministration国家食品药品监督管理局SDVSourceDataVerification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pdpharmacodynamics药物效应动力学SOPStandardOperatingProcedure标准操作规程pkpharmacokinetics药物代谢动力学SPLStudyPersonnelList研究人员名单SSLSubjectScreeningLog受试者筛选表T&RTestandReferenceProduct受试和参比试剂UAEUnexpectedAdverseEvent预料外不良事件WHOWorldHealthOrganization世界卫生组织ActiveControl阳性对照、活性对照WHO-ICDRAWHOInternationalConferenceofDrugRegulatoryAuthoritiesWHO国际药品管理当局会议Unexpectedadverseevent(UAE)预料外不良事件Audit稽查AuditReport稽查报告Auditor稽查员BlankControl空白对照Blinding/masking盲法/设盲CaseHistory病历Clinicalstudy临床研究ClinicalTrial临床试验ClinicalTrialReport临床试验报告Compliance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InformationGathering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-centerTrial多中心试验Non-clinicalStudy非临床研究OriginalMedicalRecord原始医疗记录OutcomeAssessment结果评价PatientFile病人档案PatientHistory病历Placebo安慰剂PlaceboControl安慰剂对照PreclinicalStudy临床前研究Protocol试验方案ProtocolAmendments修正案Randomization随机ReferenceProduct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（ApproximateLethalDose）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－时间曲线下面积Standardoperatingprocedure(SOP)标准操作规程Casereportform/caserecordform(CRF)病例报告表病例记录表Clinicaltrialapplication(CTA)临床试验申请Clinicaltrialexemption(CTX)临床试验免责Clinicaltrialprotocol(CTP)临床试验方案Contractresearchorganization(CRO)合同研究组织Computer-assistedtrialdesign(CATD)计算机辅助试验设计Sourcedata(SD)原始数据Electronicdatacapture(EDC)电子数据采集系统Sourcedataverification(SDV)原始数据核准Electronicdataprocessing(EDP)电子数据处理系统Subjectenrollmentlog受试者入选表Institutionreviewboard(IBR)机构审查委员会Intention-to–treat(ITT)意向性分析(－统计学）Interactivevoiceresponsesystem(IVRS)互动式语音应答系统Investigator’sbrochure(IB)研究者手册MaximumToleratedDose(MTD)最大耐受剂量Principleinvestigator(PI)主要研究者Productlicense(PL)产品许可证Seriousadverseevent(SAE)严重不良事件Seriousadversereaction(SAR)严重不良反应