临床试验常用的英文缩写

1、缩略语英文全称DCFdataclarificationformSDVsourcedataverificationADEAdverseDrugEventADRAdverseDrugReactionAEAdverseEventAIAssistantInvestigatorBMIBodyMassIndexCICo-investigatorCOICoordinatingInvestigatorCRAClinicalResearchAssociate中文全称数据澄清表，用于纸质query原始数据核对药物不良事件药物不良反应不良事件助理研究者体质指数合作研究者协调研究者临床监查员（临床监察员）CRCCli

2、nicalResearchCoordinator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EDCElectronic

3、DataCapture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旧Investigator'sBrochure研究者手册ICInformedConsent知情同意ICFInformedConsentForm知情同意书

4、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Marke

5、tingApproval/AuthorizationMedicinesControlAgencyMinistryofHealthandWelfareMAMCAMHWNDANewDrugApplicationNECNewDrugEntityNIHNationalInstitutesofHealthPIPrincipalInvestigatorPLProductLicense上市许可证英国药品监督局日本卫生福利部新药申请新化学实体国家卫生研究所（美国）主要研究者产品许可证PMAPre-marketApproval(Application)上市前许可(申请)PSIStatisticiansinthe

6、PharmaceuticalIndustry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

7、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UAEUnexpectedAdverseEve

8、nt预料外不良事件世界卫生组织WHOWorldHealthOrganizationWHO-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Coordina

9、tingCommittee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InformationGatheringInitialMeetingInspectionInstitutionInspectionInvestigationalProductInvestigatorMonitorMonitoringMonitoringPlanMonitoringReportM

10、ulti-centerTrialNon-clinicalStudyOriginalMedicalRecordOutcomeAssessmentPatientFilePatientHistoryPlaceboPlaceboControlPreclinicalStudyProtocolProtocolAmendmentsRandomization信息收集启动会议检察/视察机构检察试验药物研究者监查员（监察员）监查（监察）监查计划（监察计划）监查报告（监察报告）多中心试验非临床研究原始医疗记录结果评价病人档案病历安慰剂安慰剂对照临床前研究试验方案修正案随机SampleSize样本里、样本大小Seriousness严重性Severity严重程度SingleBlinding单目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SubjectScreen