药物临床试验英文缩写

药物临床试验英文缩写

缩略语ADE ADR AE AI BMI CI COI CRC CRF CRO CSA CTA CTX CTP CTR DSMB EDC EDP FDA FR GCP GCP GMP IB IC ICF ICH IDM IDMC IEC IND IRB IVD IVRS MA MCA MHW NDA NEC

英文全称

Adverse Drug Event Adverse Drug Reaction Adverse Event Assistant Investigator Body Mass Index Co-investigator Coordinating Investigator Clinical Research Coordinator Case Report Form Contract Research Organization Clinical Study Application Clinical Trial Application Clinical Trial Exemption Clinical Trial Protocol Clinical Trial Report Data Safety and monitoring Board Electronic Data Capture

Electronic Data Processing Food and Drug Administration Final Report Good Clinical Practice Good Laboratory Practice Good Manufacturing Practice Investigator

’s Brochure

Informed Consent Informed Consent Form International Harmonization

Independent Data Monitoring

Independent Data Monitoring Committee Independent Ethics Committee Investigational New Drug Institutional Review Board In Vitro Diagnostic Interactive Voice Response System Marketing Approval/Authorization Medicines Control Agency Ministry of Health and Welfare New Drug Application New Drug Entity

精品

Conference

on

中文全称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研究协调者病历报告表合同研究组织临床研究申请临床试验申请临床试验免责临床试验方案临床试验报告

数据安全及监控委员会电子数据采集系统电子数据处理系统美国食品与药品管理局总结报告

药物临床试验质量管理规范药物非临床试验质量管理规范药品生产质量管理规范研究者手册知情同意知情同意书国际协调会议独立数据监察独立数据监察委员会独立伦理委员会新药临床研究机构审查委员会体外诊断互动语音应答系统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

.

缩略语NIH PI PL PMA PSI QA QC RA SA SAE SAP SAR SD SD SFDA SDV SEL SI SI SIC SOP SPL SSL T&R UAE WHO WHO-ICDRA

英文全称

National Institutes of Health Principal Investigator Product License Pre-market Approval (Application) Statisticians in Industry

Quality Assurance Quality Control Regulatory Authorities Site Assessment Serious Adverse Event Statistical Analysis Plan Serious Adverse Reaction Source Data/Document Subject Diary

State Food and Drug Administration Source Data Verification Subject Enrollment Log Sub-investigator Sponsor-Investigator Subject Identification Code Standard Operating Procedure Study Personnel List Subject Screening Log Test and Reference Product Unexpected Adverse Event World Health Organization WHO International Conference of Drug Regulatory Authorities

the Pharmaceutical

中文全称

国家卫生研究所（美国）主要研究者产品许可证上市前许可（申请）制药业统计学家协会质量保证质量控制监督管理部门现场评估严重不良事件统计分析计划严重不良反应原始数据/文件受试者日记

国家食品药品监督管理局原始数据核准受试者入选表助理研究者申办研究者受试者识别代码标准操作规程研究人员名单受试者筛选表受试和参比试剂预料外不良事件世界卫生组织

WHO国际药品管理当局会议

精品

.

药物临床试验英文缩写

英文全称AccuracyActive control, AC

Adverse drug reaction, ADRAdverse event, AEAdverse medical eventsAdverse reactionAlb

ALD（Approximate Lethal DoseALP

Alpha spending functionALT

Analysis setsApproval

Assistant investigatorASTATRAUCssAudit

Audit or inspectionAudit reportAuditorBias

BioequivalenceBlank controlBlind codesBlind reviewBlind reviewBlinding methodBlinding/maskingBlockBlock sizeCarryover effectCase history

Case report form/ case record form CRF

精品

）

中文全称准确度阳性对照

活性对照

药物不良反应不良事件不良医学事件药物不良反应白蛋白近似致死剂量碱性磷酸酶消耗函数丙氨酸氨基转换酶统计分析的数据集批准助理研究者天门冬酸氨基转换酶衰减全反射法

稳态血药浓度－时间曲线下面积稽查稽查／视察稽查报告稽查员偏性偏倚生物等效应空白对照编制盲底盲态审核盲态检查盲法盲法/设盲层每段的长度延滞效应病历

病例报告表病例记录表

.

英文全称

Categorical variableCavCDCL

Clinical equivalenceClinical studyClinical study reportClinical trial

Clinical trial application CTAClinical trial exemption CTXClinical trial protocol CTPClinical trial/ study reportCmax

Co-investigator ComparisonComplianceComposite variable

Computer-assisted trial design CATDConfidence intervalConfidence levelConsistency test

Contract research organization CROContract/ agreementControl group

Coordinating committeeCrea

CRF(case report form)Crossover designCross-over StudyCssCure

Data managementDatabase

Descriptive statistical analysisDF

DichotomiesDiviation

中文全称分类变量平均浓度圆二色谱清除率临床等效应临床研究

临床试验的总结报告临床试验临床试验申请临床试验免责临床试验方案临床试验报告峰浓度合作研究者对照依从性复合变量

计算机辅助试验设计可信区间置信水平一致性检验合同研究组织协议／合同对照组协调委员会肌酐病例报告表交叉设计交叉研究稳浓度痊愈数据管理建立数据库描述性统计分析波动系统二分类偏差

精品

.

英文全称DocumentationDose-reaction relationDouble dummy

Double dummy techniqueDrop outDSC Effectiveness

Electronic data capture EDCElectronic data processing EDPEmergency envelopeEnd pointEndpoint Criteria

Endpoint criteria/ measurementEquivalence

Essential DocumentationEthics committeeExcellentExclusion criteriaFactorial designFailureFinal point

Fixed-dose procedureForced titrationFull analysis setGC－FTIRGC－MSGeneric drug

Global assessment variableGLU

Good clinical practice, GCPGood manufacture practice, GMPGood non-clinical laboratory practice, GLP

Group sequential design

Health economic evaluation, HEVHypothesis testHypothesis testing

成组序贯设计健康经济学评价假设检验假设检验中文全称记录／文件剂量－反应关系双模拟双盲双模拟技术脱落

差示扫描热量计疗效

电子数据采集系统电子数据处理系统应急信件终点终点指标终点指标等效性必需文件伦理委员会显效排除标准析因设计无效失败终点固定剂量法强制滴定全分析集

气相色谱－傅利叶红外联用气相色谱－质谱联用通用名药全局评价变量血糖

药物临床试验质量管理规范药品生产质量管理规范药物非临床研究质量管理规范

精品

.

英文全称ImprovementInclusion CriteriaInclusion criteria

Independent ethics committee IECInformation consent form ICFInformation GatheringInformed consent ICInitial meetingInspection

Institution inspectionInstitution review board, IBRIntention-to

–treat ITT

中文全称好转入选表准入选标准独立伦理委员会知情同意书信息收集知情同意启动会议检察/视察机构检查机构审查委员会

意向性分析(－统计学）互动式语音应答系统期中分析

Conference

of

人用药品注册技术要求国际技术协调会际协调会议试验药物研究者

’s brochure, IB

研究者手册

最接近一次观察的结转液相色谱－质谱联用板数致死剂量最近一次观察的结转逻辑检查定量限失访上市许可证匹配配对缺失值混合效应模式监察员监查监察计划监察报告平均滞留时间质谱

质谱－质谱联用

国

Interactive voice response system IVRSInterim analysisInternational Harmonization ICHInvestigational ProductInvestigatorInvestigator

Last observation carry forward, LOCFLC－MSLD50

LOCF, Last observation carry forwardLogic check

LOQ (Limit of Quantization)Lost of follow up

Marketing approval/ authorizationMatched pairMissing valueMixed effect modelMonitorMonitoringMonitoring PlanMonitoring ReportMRTMSMS－MS

精品

.

英文全称

MTD（Maximum Tolerated Dose）Multi-center Trial

New chemical entity NCENew drug application NDANMR

Non-clinical StudyNon-inferiority

Non-parametric statisticsObedienceODROpen-labelOptional titrationOriginal medical recordOutcome

Outcome AssessmentOutcome assessmentOutcome measurementOutlier

Parallel group designParameter estimationParametric statisticsPatient filePatient historyPer protocol PPPlaceboPlacebo controlPolytomiesPowerPrecisionPreclinical studyPrimary endpointPrimary variablePrinciple investigator PIProduct license PLProtocol

Protocol AmendmentsQuality assurance QA

中文全称最大耐受剂量多中心试验新化学实体新药申请核磁共振谱非临床研究非劣效性非参数统计方法依从性旋光光谱非盲随意滴定原始医疗记录结果结果评价结果指标评价结果指标离群值平行组设计参数估计参数统计方法病人档案病历符合方案集安慰剂安慰剂对照多分类检验效能精密度临床前研究主要终点主要变量主要研究者产品许可证试验方案修正案质量保证

精品

.

英文全称

Quality assurance unit QAUQuality control QCQuery list query formRandomizationRange checkRating scaleReference ProductRegulatory authorities RAReplicationRSDRun in

Safety evaluationSafety setSample size

Scale of ordered categorical ratingsSecondary variableSequence

Serious adverse event SAESerious adverse reaction SARSeriousnessSeveritySeveritySignificant levelSimple RandomizationSingle blindingSite audit SOP

Source data SD

Source data verification SDVSource document SDSpecificitySponsor

Sponsor-investigatorStandard curve

Standard operating procedure SOPStatistic

Statistical analysis plan

中文全称质量保证部门质量控制应用疑问表随机范围检查量表参比制剂监督管理部门可重复

日内和日间相对标准差准备期安全性评价安全性评价的数据集样本量样本大小有序分类指标次要变量试验次序严重不良事件严重不良反应严重性严重程度严重程度检验水准简单随机单盲试验机构稽查试验室的标准操作规程原始数据原始数据核准原始文件特异性申办者申办研究者标准曲线标准操作规程统计量统计分析计划

精品

.

英文全称Statistical modelStatistical tablesStratifiedStudy AuditStudy auditStudy SiteSubgroupSub-investigatorSubjectSubjectSubject diarySubject EnrollmentSubject enrollment logSubject identification code SICSubject Identification Code ListSubject RecruitmentSubject screening logSuperiority Survival analysisSXRDSystem audit

System Audit T1/2

Target variableT－BILT－CHOTest ProductTG

TLC、HPLCTmaxTP

TransformationTreatment groupTrial error

Trial Initial Meeting Trial Master FileTrial objective

中文全称统计模型统计分析表分层研究稽查研究稽查研究中心亚组助理研究者受试者受试者受试者日记受试者入选受试者入选表受试者识别代码受试者识别代码表受试者招募受试者筛选表检验生存分析

单晶X－射线衍射系统稽查系统稽查消除半衰期目标变量总胆红素总胆固醇受试制剂热重分析制备色谱峰时间总蛋白变量变换试验组试验误差试验启动会议试验总档案试验目的

精品

.

英文全称Trial siteTriple blindingTwo one-side testUn-blinding Unexpected adverse event UAEUV－VISVariabilityVariable

Visual analogy scaleVisual checkVulnerable subjectWash-outWashout period

中文全称试验场所三盲双单侧检验揭盲

预料外不良事件紫外－可见吸收光谱变异变量

直观类比打分法人工检查弱势受试者洗脱洗脱期

精品

.

实验室检查英文缩写

英文全称血常规

WBC white blood cell countGR% granulocyteLY% lymphocyte MID%

EOS% eosimophil AL% allergy lymphocyte ST%

RBC red blood cell HGB hemoglobin HCT hematocrit

红细胞比积

白细胞计数中性粒细胞百分比淋巴细胞百分比中值细胞百分比嗜酸性粒细胞百分比变异淋巴细胞百分比中性杆状粒细胞百分比红细胞计数血红蛋白红细胞比积平均红细胞体积平均红细胞血红蛋白含量

hemoglobin

平均红细胞血红蛋白浓度红细胞分布宽度变异血小板计数平均血小板体积血小板比积血小板分布宽度中文全称

MCV mean corpusular volumeMCH mean corpusular hemoglobinMCHC mean concerntration

RDW red blood cell volume distribution width

PLT/BPC platelet count

MPV mean platelet volume PCT plateletocrit

PDW platelet distribution width 尿便常规PH acidity NIT nitrite GLU glucoseSG specific gravity PRO protein BLD blood BIL bilirubin URO urobilinogen WBC white blood cell addish计数 addish count /HP high power objective /LP low power objective

count/blood

platelet

corpusular

酸碱度亚硝酸盐尿糖比重尿蛋白隐血尿胆红素尿胆原白细胞艾迪氏计数每高倍视野每低倍视野

精品

.

英文全称

OB occult blood test 体液常规

CSF cerebrospinal Pandy pandy 生化检验TB total bilirubin DB direct bilirubin TP total protein ALB albumin GLOB globulin UREA urea CREA creatinine UA uric acid GLU glucose

ALT alanine amiotransferase AST aspartate aminotransferase GGT γ-glutamyl transpeptadaseCK creatine kinase CK-MB creatine kinase-MB LDH lactate dehydrogenase

α-HBD α-hydroxybutyric dehydrogenaseAMY serum amylaseTG triglyceride CHOL cholesterol HDL-c cholesterol LDL-c cholesterol

VLDL very low-density lipoprotein Ca serum calcium Mg serum magnesium IP inorganic phosphate ALP alkaline phosphatase TBA total biliary acid ASO antistreptolysin a-AG a－acid glycoprotein CRP C-reactive protein CRF rheumatoid factor MTP mili-total protein

极低密度脂蛋白钙镁无机磷碱性磷酸酶总胆汁酸抗链球菌溶血素a－酸性糖蛋白反应蛋白类风湿因子微量蛋白精品

O

low-density

lipoprotein

低密度脂蛋白

high-density

lipoprotein

总胆红素直接胆红素总蛋白白蛋白球蛋白尿素肌肝尿酸血糖

丙氨酸氨基转移酶门冬氨酸氨基转移酶谷氨酰转肽酶肌酸肌酶肌酸肌酶同工酶乳酸脱氢酶α－羟丁酸脱氢酶血淀粉酶肝油三脂胆固醇高密度脂蛋白脑积夜庞氏试验中文全称大便隐血试验

.

英文全称

IgG immunoglobin G IgA immunoglobin A IgM immunoglobin M C3 complement C3 C4 complement C4 cTNT troponin T MYOG myoglobin电解质Na sodium K kalium Cl chloride Ga calciumMg magnesium乙肝标志物

HBV hepatitis B virus

HBsAg hepatitis B surface antigen HBsAb antibody antigen

HBcAg hepatitis B core antigen HBcAb antibody antigen

HBeAg hepatitis B e-antigen

HBeAb antibody to hepatitis B e-antigenELISA enzymelinked immunosorbentassyHAV hepatitis A virus HCV hepatitis C virus 输血免疫全套HBV hepatitis B virus HCV hepatitis C virus TP treponema pallidum

HIV human immunodeficiency virus

乙型肝炎病毒丙型肝炎病毒梅毒螺旋体人类免疫缺陷病毒乙肝e抗原乙肝e抗体酶联免疫吸附试验甲肝病毒丙肝病毒

to

hepatitis

B core

乙肝核心抗原乙肝核心抗体

to

hepatitis

surface

乙肝病毒乙肝表面抗原乙肝表面抗体钠钾氯钙镁中文全称免疫球蛋白G 免疫球蛋白A 免疫球蛋白M 补体C3 补体C4 肌钙蛋白T 肌红蛋白

如有侵权请联系告知删除，感谢你们的配合！

精品