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1、GCP常见英文缩写中文全称药物不良事件药物不良反响 不良事件缩略语英文全称ADE Adverse Drug Event ADR Adverse Drug Reaction AE Adverse EventCI Co-investigatorCOI Coordinating InvestigatorCRA Clinical Research AssociateAI Assistant InvestigatorBMI Body Mass Index助理研究者体质指数合作研究者协调研究者临床监查员（临床监察员）临床研究协调者CRC Clinical Research CoordinatorCRF C
2、ase Report Form病历报告表CRO Contract Research Organization合同研究组织CSA Clinical Study ApplicationCSA Clinical Study Agreement临床研究申请临床研究协议CTA Clinical Trial ApplicationCTXClinicalTrialExemptionCTPClinicalTrialProtocolCTRClinicalTrialReport临床试验申请临床试验免责临床试验方案 临床试验报告DSMB Data Safety and monitoring Board 数据平安及监
3、控委员会EDC Electronic Data Capture电子数据采集系统EDP Electronic Data Processing电子数据处理系统FA Financial Agreement财务协议FDA Food and Drug Administration FR Final Report GCP Good Clinical Practice GLPGood Laboratory PracticeGMP Good Manufacturing Practice IBInvestigator s BrochureICInformed ConsentICFInformed Consent
4、 FormICH IDM IDMC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Harmonization国际协调会议International Conference onIndependent Data Monitoring独立数据监察Independent Data Monitoring Committee 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IEC Independent Ethics Committee IND Investigational New Drug IRB Institut
5、ional Review BoardIVD In Vitro Diagnostic体外诊断IVRS Interactive Voice Response System 互动语音应答系统MA Marketing Approval/Authorization 上市许可证MCA Medicines Control Agency英国药品监督局MHW Ministry of Health and Welfare日本卫生福利部NK Not know CRF中药用剂量或时间不明ND Not detectedCRF中未查或漏查NDANew Drug Application新药申请NECNew Drug Ent
6、ity新化学实体NIH National Institutes of Health国家卫生研究所（美国）主要研究者PI Principal InvestigatorPL Product License产品许可证PMA Pre-market Approval （Application）上市前许可（申请）PSI Statisticians in the Pharmaceutical Industry 制药业统计学家协会QAQuality AssuranceQCQuality ControlRA Regulatory Authorities SASite AssessmentSAESerious A
7、dverseEventSAP Statistical Analysis Plan SAR Serious Adverse Reaction SDSource Data/DocumentSDSubject Diary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响原始数据/文件 受试者日记SFDA State Food and Drug Administration 国家食品药品监督管理局SDV Source Data Verification原始数据核准SEL Subject Enrollment Log受试者入选表SI Sub-investigator助理研究者SI
8、Sponsor-InvestigatorSIC Subject Identification Code申办研究者受试者识别代码SOP Standard Operating Procedure标准操作规程SPL Study Personnel List SSL Subject Screening Log T&R Test and Reference Product UAE Unexpected Adverse Event WHO World Health Organization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-ICDRA WHO Internation
9、al Conference of Drug Regulatory Authorities WHO 国际药品管理当局会议Active ControlAuditAudit ReportAuditorBlank Control Blinding/maskingCase History阳性对照、活性对照稽查稽查报告稽查员空白对照盲法/设盲病历Clinical studyClinical TrialClinical Trial Report Compliance Coordinating Committee Cross-over Study临床研究临床试验临床试验报告依从性协调委员会 交叉研究Doubl
10、e Blinding双盲Endpoint Criteria/measurementEssential DocumentationExclusion CriteriaInclusion CriteriaSubject Identification Code ListInformation Gathering Initial Meeting Inspection Institution Inspection Investigational Product Investigator Monitor Monitoring Monitoring Plan Monitoring Report Multi-
11、center Trial Non-clinical Study Original Medical Record Outcome Assessment Patient File Patient History Placebo Placebo Control Preclinical Study Protocol Protocol Amendments Randomization Reference Product Sample Size Seriousness SeveritySingle BlindingSponsorStudy AuditSubjectSubject EnrollmentSub
12、ject Enrollment Log 终点指标必需文件排除标准入选表准信息收集启动会议检察/视察机构检察试验药物研究者监查员（监察员）监查（监察）监查计划（监察计划）监查报告（监察报告） 多中心试验非临床研究原始医疗记录结果评价病人档案病历抚慰剂抚慰剂对照临床前研究试验方案修正案随机参比制剂样本量、样本大小严重性严重程度单盲申办者研究稽查受试者受试者入选受试者入选表受试者识别代码表Subject Recruitment Study SiteSubject Screening Log System Audit Test ProductTrial Initial Meeting Trial Master File Trial Objective Triple Blinding Wash-out Wash-out Period受试者招募研究中心受试者筛选表系统稽查受试制剂试验启动会议试验总档案试验目的三盲洗脱洗脱期