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1、【实用】GCP资料药物临床试验英文缩写缩略语英文全称中文全称ADEAdverse Drug Event药物不良事件ADRAdverse Drug Reaction药物不良反响AEAdverse Event不良事件AIAssistant Investigator助理研究者BMIBody Mass Index体质指数CICo-investigator合作研究者COICoordinating Investigator协调研究者CRCClinicalResearchCoordinator临床研究协调者CRFCase Report Form病历报告表CROContractResearchOrganiza
2、tion合同研究组织CSAClinicalStudyApplication临床研究申请CTAClinicalTrialApplication临床试验申请CTXClinical Trial Exemption临床试验免责CTPClinical Trial Protocol临床试验方案CTRClinical Trial Report临床试验报告DSMBData Safety and monitoring数据平安及监控委员药海无涯学无止境专注医学领域【实用】GCP资料英文全称DescriptivestatisticalanalysisDFDichotomiesDiviationDocumentati
3、onDose-reaction relationDouble dummyDouble dummy techniqueDrop outDSCEffectivenessElectronic data capture EDCElectronic data processingEDPEmergency envelopeEnd pointEndpoint CriteriaEndpointcriteria/measurement中文全称描述性统计分析波动系统二分类偏差记录/文件剂量一反响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八、终点指标终点指标药海无涯学
4、无止境专注医学领域【实用】GCP资料药海无涯学无止境专注医学领域英文全称中文全称Equivalence等效性Essential Documentation必需文件Ethics committee伦理委员会Excellent显效Exclusion criteria排除标准Factorial design析因设计Failure无效失败Final point终点八、Fixed-dose procedure固定剂量法Forced titration强制滴定Full analysis set全分析集GC-FTIR气相色谱一傅利叶红外联用GC-MS气相色谱一质谱联用Generic drug通用名药Glob
5、al assessment variable全局评价变量GLU血糖Good clinical practice, GCP药物临床试验质量治理标准Good manufacture practice,GMP药品生产质量治理标准Goodnon-clinical药物非临床研究质量治理规【实用】GCP资料英文全称laboratory practice, GLPGroup sequential designHealth economic evaluation,HEVHypothesis testHypothesis testingImprovementInclusion CriteriaInclusion
6、 criteriaIndependentethicscommittee IECInformation consent formICFInformation GatheringInformed consent ICInitial meetingInspectionInstitution inspectionInstitution review board,IBR中文全称范成组序贯设计健康经济学评价假设检验假设检验好转入选标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药海无涯学无止境专注医学领域【实用】GCP资料英文全称Intention-to - t
7、reat ITTInteractive voice responsesystem IVRSInterim analysisInternational Conference ofHarmonization ICHInvestigational ProductInvestigatorInvestigators brochure,IBLast observation carryforward, LOCFLC-MSLD50LOCF, Last observation carry forwardLogic checkLOQ (Limit of Quantization)Lost of follow up
8、Marketingapproval/中文全称意向性分析（一统计学）互动式语音应答系统期中分析人用药品注册技术要求国际技术协调会国际协调会议试验药物研究者研究者手册最接近一次观察的结转液相色谱一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药海无涯学无止境专注医学领域【实用】GCP资料药海无涯学无止境专注医学领域英文全称中文全称authorizationMatched pair匹配配对Missing value缺失值Mixed effect model混合效应模式Monitor监察员Monitoring监查Monitoring Plan监察方案Monitoring Repor
9、t监察报告MRT平均滞留时间MS质谱MS-MS质谱一质谱联用MTD (Maximum Tolerated Dose)最大耐受剂量Multi-center Trial多中央试验New chemical entity NCE新化学实体New drug application NDA新药申请NMR核磁共振谱Non-clinical Study非临床研究Non-inferiority非劣效性Non-parametric statistics非参数统计方法Obedience依从性【实用】GCP资料英文全称ODROpen-labelOptional titrationOriginal medical re
10、cordOutcomeOutcome AssessmentOutcome assessmentOutcome measurementOutlierParallel group designParameter estimationParametric statisticsPatient filePatient historyPer protocol PPPlaceboPlacebo controlPolytomiesPowerPrecision中文全称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抚慰剂抚慰剂对照多分类检
11、验效能精密度药海无涯学无止境专注医学领域【实用】GCP资料药海无涯学无止境专注医学领域英文全称中文全称Preclinical study临床前研究Primary endpoint主要终点一y、八、Primary variable主要变量Principle investigator PI主要研究者Product license PL产品许可证Protocol试验方案Protocol Amendments修正案Quality assurance QA质量保证Quality assurance unit QAU质量保证部门Quality control QC质量限制Query list query
12、form应用疑问表Randomization随机Range check范围检查Rating scale量表Reference Product参比制剂Regulatory authorities RA监督治理部门Replication可重复RSD日内和日间相对标准差Run in准备期Safety evaluation平安性评价【实用】GCP资料英文全称Safety setSample sizeScale of ordered categorical ratingsSecondary variableSequenceSerious adverse event SAESerious adverse
13、reaction SARSeriousnessSeveritySeveritySignificant levelSimple RandomizationSingle blindingSite auditSOPSource data SDSource data verification SDVSource document SDSpecificity中文全称平安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响严重性严重程度严重程度检验水准简单随机单目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药海无涯学无止境专注医学领域【实用】GCP资料英文
14、全称SponsorSponsor-investigatorStandard curveStandardoperatingprocedure SOPStatisticStatistical analysis planStatistical modelStatistical tablesStratifiedStudy AuditStudy auditStudy SiteSubgroupSub-investigatorSubjectSubjectSubject diarySubject EnrollmentSubject enrollment log中文全称申办者申办研究者标准曲线标准操作规程统计量
15、统计分析方案统计模型统计分析表分层研究稽查研究稽查研究中央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药海无涯学无止境专注医学领域【实用】GCP资料药海无涯学无止境专注医学领域英文全称中文全称Subject identification codeSIC受试者识别代码Subject Identification CodeList受试者识别代码表Subject Recruitment受试者招募Subject screening log受试者筛选表Superiority检验Survival analysis生存分析SXRD单品乂一射线衍射System audit系统稽查System A
16、udit系统稽查Tl/2消除半衰期Target variable目标变量T-BIL总胆红素T-CHO总胆固醇Test Product受试制剂TG热重分析TLC、 HPLC制备色谱Tmax峰时间TP总蛋白【实用】GCP资料缩略语英文全称中文全称Board会EDCElectronic Data Capture电子数据采集系统EDPElectronicDataProcessing电子数据处理系统FDAFoodandDrugAdministration美国食品与药品治理局FRFinal Report总结报告GCPGood Clinical Practice药物临床试验质量管理标准GCPGood Lab
17、oratory Practice药物非临床试验质量治理标准GMPGoo dManu f ac t ur ingPractice药品生产质量治理规范IBInvestigator s Brochure研究者手册ICInformed Consent知情同意ICFInformed Consent Form知情同意书I CHInternational Conferenceon Harmonization国际协调会议IDMIndependentDataMonitoring独立数据监察IDMCIndependentData独立数据监察委员会药海无涯学无止境专注医学领域【实用】GCP资料英文全称Transfo
18、rmationTreatment groupTrial errorTrial Initial MeetingTrial Master FileTrial objectiveTrial siteTriple blindingTwo one-side testUn-blindingUnexpected adverse eventUAEUV-VISVariabilityVariableVisual analogy scaleVisual checkVulnerable subjectWash-outWashout period中文全称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试验场所* _
19、.目双单侧检验揭盲预料外不良事件紫外一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药海无涯学无止境专注医学领域【实用】GCP资料药海无涯学无止境专注医学领域【实用】GCP资料实验室检查英文缩写药海无涯学无止境专注医学领域英文全称中文全称血常规WBC white blood cell count白细胞计数GR% granulocyte中性粒细胞百分比LY% lymphocyte淋巴细胞百分比MID%中值细胞百分比EOS% eosimophil嗜酸性粒细胞百分比AL% allergy lymphocyte变异淋巴细胞百分比ST%中性杆状粒细胞百分比RBC red blood ce
20、ll红细胞计数HGB hemoglobin血红蛋白HCT hematocrit红细胞比积红细胞比积MCV mean corpusular volume平均红细胞体积【实用】GCP资料英文全称中文全称MCHmeancorpusular hemoglobin平均红细胞血红蛋白含量MCHCmeancorpusularhemoglobin concerntration平均红细胞血红蛋白浓度RDW red blood cell volume distribution width红细胞分布宽度变异PLT/BPCplateletcount/blood platelet count血小板计数MPV mean
21、platelet volume平均血小板体积PCT plateletocrit血小板比积PDW platelet distribution width血小板分布宽度尿便常规PH acidity酸碱度NIT nitrite亚硝酸盐GLU glucose尿糖SG specific gravity比重PRO protein尿蛋白BLD blood隐血BIL bilirubin尿胆红素URO urobilinogen尿胆原药海无涯学无止境专注医学领域【实用】GCP资料药海无涯学无止境专注医学领域英文全称中文全称WBC white blood cell白细胞addish 计数 addish count艾
22、迪氏计数/HP high power objective每高倍视野/LP low power objective每低倍视野OB occult blood test大便隐血试验体液常规CSF cerebrospinal脑积夜Pandy pandy庞氏试验生化检验TB total bilirubin总胆红素DB direct bilirubin直接胆红素TP total protein总蛋白ALB albumin白蛋白GLOB globulin球蛋白UREA urea尿素CREA creatinine肌肝UA uric acid尿酸GLU glucose血糖ALT alanine amiotran
23、sferase丙氨酸氨基转移酶ASTaspartate门冬氨酸氨基转移酶【实用】GCP资料英文全称中文全称aminotransferaseGGTY-glutamyltranspeptadase谷氨酰转肽酶CK creatine kinase肌酸肌酶CK-MB creatine kinase-MB肌酸肌酶同工酶LDH lactate dehydrogenase乳酸脱氢酶a -HBD a -hydroxybutyricdehydrogenasea一羟丁酸脱氢酶AMY serum amylase血淀粉酶TG triglyceride肝油三脂CHOL cholesterol胆固醇HDL-chigh-d
24、ensitylipoprotein cholesterol高密度脂蛋白LDL-c1ow-densitylipoprotein cholesterol低密度脂蛋白VLDL very low-density lipoprotein极低密度脂蛋白Ca serum calcium钙Mg serum magnesium镁IP inorganic phosphate无机磷ALP alkaline phosphatase碱性磷酸酶药海无涯学无止境专注医学领域【实用】GCP资料英文全称TBA total biliary acidASO antistreptolysina AG a acid glycoprot
25、einCRP C-reactive protein CRF rheumatoid factorMTP mili-total proteinIgG immunoglobin GIgA immunoglobin AIgM immunoglobin MC3 complement C3C4 complement C4cTNT troponin TMYOG myoglobin电解质Na sodiumK kaliumCl chlorideGa calciumMg magnesium乙肝标志物中文全称总胆汁酸抗链球菌溶血素0a 一酸性糖蛋白反响蛋白类风湿因子微量蛋白免疫球蛋白G免疫球蛋白A免疫球蛋白M补体C
26、3补体C4肌钙蛋白T肌红蛋白钠钾氯钙镁药海无涯学无止境专注医学领域【实用】GCP资料英文全称HBV hepatitis B virusHBsAg hepatitis B surface antigenHBsAb antibody to hepatitis surface antigenHBcAg hepatitis B core antigenHBcAb antibody to hepatitisB core antigenHBeAg hepatitis B e-antigenHBeAb antibody to hepatitisB e-antigenELISAenzymelinkedimmu
27、nosorbentassyHAV hepatitis A virusHCV hepatitis C virus输血免疫全套HBV hepatitis B virusHCV hepatitis C virusTP treponema pallidumHIV human immunodefic iency中文全称乙肝病毒乙肝外表抗原乙肝外表抗体乙肝核心抗原乙肝核心抗体乙肝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药海无涯学无止境专注医学领域【实用】GCP资料英文全称中文全称virus药海无涯学无止境专注医学领域【实用】GCP资料药海无涯学无止
28、境专注医学领域缩略语英文全称中文全称Monitoring CommitteeIECIndependentEthicsCommittee独立伦理委员会INDInvestigational New Drug新药临床研究IRBInstitutionalReviewBoard机构审查委员会IVDIn Vitro Diagnostic体外诊断IVRSInteractiveVoiceResponse System互动语音应答系统MAMarketingApproval/Authorization上市许可证MCAMedicines Control Agency英国药品监督局MHWMinistry of Hea
29、lth andWelfare日本卫生福利部NDANew Drug Application新药申请NECNew Drug Entity新化学实体NIHNational Institutes ofHealth国家卫生研究所美国）PIPrincipal Investigator主要研究者PLProduct License产品许可证PMAPre-marketApproval上市前许可（申请）【实用】GCP资料缩略语英文全称中文全称(Application)PSIStatisticians in thePharmaceutical Industry制药业统计学家协会QAQuality Assurance
30、质量保证QCQuality Control质量限制RARegulatory Authorities监督治理部门SASite Assessment现场评估SAESerious Adverse Event严重不良事件SAPStatistical Analysis Plan统计分析方案SARSerious Adverse Reaction严重不良反响SDSource Data/Document原始数据/文件SDSubject Diary受试者日记SFDAState Food and DrugAdministration国家食品药品监督管理局SDVSource Data Verification原始数
31、据核准SELSubject Enrollment Log受试者入选表SISub-investigator助理研究者SISponsor-Investigator申办研究者SICSubject IdentificationCode受试者识别代码药海无涯学无止境专注医学领域【实用】GCP资料缩略语英文全称中文全称SOPStandardOperatingProcedure标准操作规程SPLStudy Personnel List研究人员名单SSLSubject Screening Log受试者筛选表T&RTest and Reference Product受试和参比试剂UAEUnexpected Ad
32、verse Event预料外不良事件WHOWorld Health Organization世界卫生组织WHO-ICDRAWHOInternationalConference ofDrugRegulatoryAuthoritiesWHO国际药品治理当局会议药海无涯学无止境专注医学领域【实用】GCP资料药物临床试验英文缩写英文全称AccuracyActive control, ACAdverse drug reaction, ADRAdverse event, AEAdverse medical eventsAdverse reactionAlbALD ( Approximate LethalD
33、ose)ALPAlpha spending functionALTAnalysis setsApproval中文全称准确度阳性对照活性对照药物不良反响不良事件不良医学事件药物不良反响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药海无涯学无止境专注医学领域【实用】GCP资料英文全称Assistant investigatorASTATRAUCssAuditAudit or inspectionAudit reportAuditorBiasBioequivalenceBlank controlBlind codesBlind reviewBlind reviewBlin
34、ding methodBlinding/maskingBlockBlock sizeCarryover effect中文全称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一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百态审核盲态检查盲法盲法/设盲层每段的长度延滞效应药海无涯学无止境专注医学领域【实用】GCP资料英文全称Case historyCase report form/ case record form CRFCategorical variableCavCDCLClinical equivalenceClinical studyClinical s
35、tudy reportClinical trialClinical trial applicationCTAClinical trial exemptionCTXClinical trial protocol CTPClinical trial/ study reportCmaxCo-investigatorComparison中文全称病历病例报告表病例记录表分类变量平均浓度圆二色谱去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药海无涯学无止境专注医学领域【实用】GCP资料英文全称ComplianceComposite v
36、ariableComputer-assistedtrialdesign CATDConfidence intervalConfidence levelConsistency testContractresearchorganization CROContract/ agreementControl groupCoordinating committeeCreaCRF (case report form)Crossover designCross-over StudyCssCureData managementDatabase中文全称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酎病例报告表交叉设计交叉研究稳浓度痊愈数据治理建立数据库药海无涯学无止境专注医学领域