临床试验常用的英文缩写

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范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ICHInternationalConferenceonHarmonization国际协调会议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IVRSInteractiveVoiceResponseSystem互动语音应答系统MAMarketingApproval/Authorization上市许可证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SOPStandardOperatingProcedure标准操作规程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WHO-ICDRAWHOInternationalConferenceofDrugRegulatoryAuthoritiesWHO国际药品管理当局会议ActiveControl阳性对照、活性对照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StudySite研究中心SubjectScreeningLog受试者筛选表SystemAudit系统稽查TestProduct受试制剂TrialInitialMeeting试验启动会议TrialMasterFile试验总档案TrialObjective试验目的TripleBlinding三盲Wash-out洗脱Wash-outPeriod洗脱期