《临床监查员CRA需要学习的相关名词》.docx

临床监察员相关名词缩写语英语全称中文全称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BABioavaliability生物利用度BEBioavaliability生物等效性BMIBodyMassIndex体质指数CICo~investigator合作研究者COICoordinatingInvestigator协调研究员CRAClinicalResearchAssociate临床监察员CRCClinicalResearchCoordinator临床研究协调员CRFClinicalResearchForm病例报告表CROContractResearchOrganization合同研究组织CSAClinicalStudyApplication临床研究申请CTAClinicalTrialApplication临床试验+请药物临床试验网CTXClinicalTrialExemption临床试验免资CTPClinicalTrialProtocol临床试验方案CTRClinicalTrialReport临床试验才聘DSMBDataSafetyandmonitoringBoard数据安全及监控委员会ECEthnicsCommittee伦理委员会EDCElectronicDataCapture电子数据米集系统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药物临床试验质虽管理规范GLPGoodLaboratoryPractice药物非临床试验质录许理规范GMPGoodManufacturingPractice药品生产庚m规范IBInvestigator*sBrochure研究者手册ICInformedConsent知情同意ICFInformedConsentForm知情同意书ICHInternationalConferenceonHarmonizationOfTechnicalRequirementsforRegistrationofpharmaceuticalsforHumanuse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MAMarketingApprova1Authorization上市许可证MCAMedicinesControlAgency英国药品监督局MHWMinistryofHealthandWelfare日木卫生福利部NDANewDrugApplication新药申请NECXewDrugEntity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PKpharmacokinetics药物代谢动力学PMAPre-marketApproval(Application)上市前许可（申请）PSIStatisticiansinthePharmaceuticalIndustry制药业统计学家协会QAQualityAssurance质虽保证QCQualityControl质虽控制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中办研究者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预料外不心B件WHOWorldHealthOrganization世界卫生组织WHO-ICDRAWHOInternationalConferenceofDrugRegulatoryAuthoritiesWHC®际药品管理当局会议常见中英文对照表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临床试验才聘Compliance依从性CoordinatingCommittee协调委员会Cross-overStudy交叉研究DoubleBlinding双盲DeclarationofHelisinki赫尔辛基宣吉EndpointCriteria/measurement终点指标EssentialDocumentation必需文件ExclusionCriteria排除标准InclusionCriteria入选表准InformationGathering侑息收集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样木虽、样木大小Seriousness严重隹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二盲Wash-out洗脱Wash"outPeriod洗脱期。