临床试验常用的英文缩写

1、专业术语缩略语英文全称称ADEAdverse Drug中文全Eve nt药物不良事件ADR Adverse DrugReacti on药物不良反应AEAdverseEve nt不良事件Al Assista ntIn vestigator助理研究者BMI Body MassIn dex指数体质ClCo-i nv estigatorCOI合作研究者Coord in ati ng Inv estigator协调研究者CRA Clinical Research Associate临床监查员（临床监察员）CRCCli nical Research Coordin ator临床研究协调者CRFCase R

2、eportForm病历报告表CROCon tract ResearchOrga ni zatio n合同研究组织CSA ClinicalStudy Applicatio n临床研究申请CTA ClinicalTrial Applicati on临床试验申请CTXClinical Trial Exemption临床试验免责CTPCli nical TrialProtocol临床试验方案CTRCli nical TrialReport临床试验报告DSMB Data Safety and mon itori ng Board数据安全及监控委员会EDCElectro nic DataCapture电子

3、数据米集系统EDP Electro nic Data Process ing电子数据处理系统国食品与药品管理局FRFinal总结Report报告GCP Good Cli nicalPractice药物临床试验质量管理规范GLPGood Laboratory Practice药物非临床试验质量管理规范GMP Good Manu facturi ng Practice药品生产质量管理规范IBInvestigator ' s Brochure研究者手册ICIn formedConsent知情同意ICFIn formed ConsentForm知情同意书ICHIntern ati onal C

4、onference on Harmoni zati on国际协调会议IDMIndependent Data Monitoring独立数据监察IDMCIn depe ndent Data Mon itori ng Committee独立数据监察委员会IECIn depe ndent Ethics Committee独立伦理委员会INDInv estigati onal New Drug新药临床研究IRBIn stituti onal Review Board机构审查委员会IVDIn VitroDiag no Stic体外诊断IVRSIn teractive Voice Resp onse Sys

5、tem互动语音应答系统MAMarketing Approval/Authorization上市许可证MCAMedici nes Con trol Age ncy英国药品监督局MHWMinistryof Health and Welfare日本卫生福利部NDANew DrugApplicatio n新药申请NECNew DrugEn tity新化学实体家卫生研究所（美国）PIPrin cipalInv estigatorPLProductLice nse品许可证PMAPre-market请）PSIStatisticia ns药业统计学家协会QAQualityAssura neeQCQuality

6、Con trol量控制RARegulatoryAuthoritiesSASiteAssessme nt现场评估主要研究者产Approval （Application）上市前许可（申in the Pharmaceutical Industry制质量保证质监督管理部门SAESerious AdverseSAPStatisticalAnalysis Plan统计分析计划SARSerious Adverse Reacti on严重不良反应SDSourceData/Docume nt原始数据/文件SDSubjectDiary受试者日记SFDAState Food and Drug Admi nistra

7、tio n国家食品药品监督管理局SDVSource Data Verificati on原始数据核准SELSubject En rollme ntLog受试者入选表SISub-i nv estigator助理研究者SISponsor-lnv estigator申办研究者SICSubject Ide ntificatio nCode受试者识别代码SOP程SPLListSSLLogT&R和参比试剂UAE不良事件WHO生组织Standard Operating Procedure标准操作规Study Pers onnel研究人员名单Subject Scree ning受试者筛选表Test a

8、nd Refere nee Product受试Un expected Adverse EventWorld Health Organization预料外世界卫WHO-ICDRA WHO In ternatio nal Co nfere nee of Drug RegulatoryAuthoritiesWHO国际药品管理当局会议ActiveCon trol阳性对照、活性对照Audit稽查Audit Report稽查报告Auditor空白对照病历临床研究临床试验临床试验报协调委员会交叉研究双盲终点指标稽查员Bia nkCon trolBli ndin g/maski ng盲法/设盲CaseHist

9、oryCli nicalstudyCli nicalTrialCli nical Trial Report告Complia nee依从性Coordin ati ng CommitteeCross-overStudyDoubleBli ndi ngEndpoint Criteria/measurementEsse ntial Docume ntati on必需文件Exclusi onCriteriaIn clusio nCriteriaInformation GatheringIn itialMeet ingIn specti on检察/视察In stituti on In specti onI

10、nv estigati onal ProductInv estigator研究者Mo nitor监查员（监察员）Mon itori ng监查（监察）Mon itori ngPla n计划）排除标准入选表准信息收集启动会议机构检察试验药物监查计划（监察Mon itori ngReport监查报告（监察报告）Multi-ce nterTrial多中心试验Non-cli nicalStudy非临床研究Original Medical Record原始医疗记录Outcome Assessme nt结果评价Patie ntFile病人档案Patie ntHistory病历Placebo安慰剂Placeb

11、o Con trol安慰剂对照Precli nicalStudy临床前研究Protocol试验方案Protocol Ame ndme nts修正案Ran domizati on随机Refere neeProduct参比制剂SampleSize样本量、样本大小Serious ness严重性Severity严重程度Si ngleBli ndi ng单盲Sponsor申办者StudyAudit研究稽查Subject受试者SubjectEn rollme nt受试者入Subject En rollme nt LogSubject Identification Code ListSubject Recruitme nt募StudySite研究中心Subject Scree ning Log表SystemAuditTestProduct剂Trial In i