临床试验常见英语词汇

临床试验常见英语词汇临床试验英语词汇，无疑是“新手上路”的第一大难题，以下是跟大家介绍临床试验常见英语词汇，欢送大家阅读!ClinicalTrial临床试验Protocol试验方案Synopsis摘要StudyObjective研究目的StudyEndpoint研究终点StudyDesign研究设计StudyProcedure研究流程StudyCompletion研究完成StudyTermination研究终止Baseline基线InclusionCriteria入组标准ExclusionCriteria排除标准IVRS-InteractiveVoiceResponseSystem交互式语音应答系统IWRS-InteractiveWebResponseSystem交互式网络应答系统SDV-SourceDataVerification原始数据核查EDC-ElectronicDataCapture电子数据采集StatisticalMethods统计学方法SingleBlinding单盲DoubleBlinding双盲Placebo抚慰剂PlaceboControl抚慰剂对照ActiveControl阳性对照、活性对照BlankControl空白对照Blinding/Masking盲法/设盲Randomized,Double-blindStudy随机对照双盲试验OuteAssessment结果评价Multi-centerTrial多中心试验OS-OverallSurvival总生存期PFS-ProgressionFreeSurvival无进展生存期Contract/Agreement合同/协议GCP-GoodClinicalPractice药物临床试验质量管理标准GMP-GoodManufacturingPractice药品生产质量管理标准SOP-StandardOperatingProcedure标准操作规程ProtocolAmendments修正案CRF-CaseReportForm病历报告表IB-Investigator’sBrochure研究者手册ICF-InformedConsentForm知情同意书QA-QualityAssurance质量保证QC-QualityControl质量控制Monitoring监查Monitor监查员Audit稽查Auditor稽查员Inspection视察CFDA-ChinaFoodandDrugAdministration国家食品药品监督管理局FDA-FoodandDrugAdministration美国食品与药品监督管理局ICH-InternationalConferenceonHarmonization国际协调会议IECIndependentEthicsCommittee独立伦理委员会IRB-InstitutionalReviewBoard机构审查委员会Sponsor申办者CRO-ContractResearchOrganization合同研究组织SMO-SiteManagementOrganization现场管理组织InvestigationalSite研究中心Investigator研究者PI-PrincipalInvestigator主要研究者SI-Sub-investigator助理研究者CRC-ClinicalResearchCoordinator临床研究协调员InitialMeeting启动会SIV-SiteInitiationVisit中心启动访视Subject受试者SubjectScreeningLog受试者筛选表SubjectEnrollmentLog受试者入选表SubjectIdentificationCode受试者识别代码FPI/FSI-FirstPatient/SubjectIn首例受试者入组LPI/LSI-LastPatient/SubjectIn末例受试者入组LPO/LSO-LastPatient/SubjectOut末例受试者出组Recruitment招募Screening筛选Randomization随机Enrollment入组Visit访视VisitWindow访视窗口期OutofVisitWindow超窗FollowUp随访Withdrawal脱落Compliance依从性Wash-outPeriod洗脱期Cycle周期TreatmentAllocation治疗分配PatientFile病人档案CaseRecord/MedicalHistory病历SD-SourceData/Document/Documentation原始数据/文件SubjectDiary受试者日记Demography人口统计学DOB-DateofBirth出生日期Race种族PhysicalExam体格检查VitalSigns生命体征Height身高Weigh体重Temperature体温Pulse/Heartrate脉搏/心率SystolicBloodPressure收缩压DiastolicBloodPressure舒张压ECG-Electrocardiogram心电图ChestX-ray胸部X光Image影像学LaboratoryAssessment实验室评估CS/NCS-ClinicalSignificant/Non-ClinicalSignificant有临床意义/无临床意义Hematology/BloodRoutineTest血液学/血常规Hemoglobin血红蛋白Platelets血小板RBC-RedBloodCell红细胞WBC-WhiteBloodCell白细胞Neutrophils中性粒细胞Lymphocytes淋巴细胞Monocytes单核细胞Eosinophils嗜酸性粒细胞Basophils嗜碱性粒细胞Urinalysis尿液分析Glucose葡萄糖Ketones酮体Leukocytes粒性白细胞Nitrite亚硝酸盐Bilirubin胆红素Protein蛋白Crystals晶体pH酸碱度BloodBiochemistry血液生化Calcium钙Magnesium镁Phosphorus磷Sodium钠Potassium钾Chloride氯Creatinine肌酐BUN-BloodUreaNitrogen尿素氮TP-TotalProtein总蛋白Albumin白蛋白AST/SGOT谷草转氨酶/门冬氨酸氨基转移酶ALT/SGPT谷丙转氨酶/丙氨酸氨基转移酶ALP-AlkalinePhosphatase碱性磷酸酶TB-TotalBilirubin总胆红素LDH乳酸脱氢酶GGT谷氨酰转氨酶Glucose葡萄糖BloodCoagulation凝血PT-ProthrombinTime凝血酶原时间PT-INR凝血酶原时间-国际标准化比值APTT活化局部凝血活酶时间IP-InvestigationalProduct研究产品CM-ConitantMedication合并用药DrugReceive药物接收DrugStorage药物储存DrugDispense药物分发DrugReturn药物返还DrugDestroy药物销毁Quantity数量MedicationNo.研究药品编号Packaging包装Labeling标签DrugAountability药物清点DrugAdministration药物使用Overdose药物过量DoseReduce剂量降低DoseInterrupt剂量中断（暂停）DoseDiscontinuation剂量终止（完全终止）ADR-AdverseDrugReaction药物不良反响AE-AdverseEvent不良事件SAESeriousAdverseEvent严重不良事件Seriousness严重性（性质）Severity严重程度（程度）Grade级别Resultsindeath导致死亡Lifethreatening危急生命Requiresorprolongshospitalization导致或延长住院时间Congenitalanomaly/Birthdefect先天畸形/出生缺陷Persistentorsignificantdisability/incapacity永久或重大伤残/丧失工作能力Mild轻度Moderate中度Severe重度SafetyAssessment/Evaluation平安评估SUSAR=SeriousandUnexpectedSuspectedAdverseReaction严重的非预期疑似相关的药品不良反响Anemia贫血（血红蛋白降低）Hemoglobinincreased血红蛋白升高Hypertension高血压Hypotension低血压Abdomin