CRA专业术语中英文对照

1、屮文金称药物不良事件药物不良反应不良事件助理研究再体质指数合作研究者协调研究者临床监查员（临床监察员）临床研究协调者缩略语英文金称adeadverse drug eventadr adverse drug react io naeadverse eve ntal assistant investigatorbmi body mass indexclco-investigatorco icoordi nating investigatorcra clinical research associatecrc clinical research coordinatorcrf case report

2、form病历报告表cro contract research organization合同研究组织csa clinical study applicationcsa clinical study agreementcta clinical trial applicationctxclinicaltrialexemptionctpclinicaltrialprotocolctrclinicaltrialreport临床研究审请临床研究协议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 数据安全及监控委员会edc elec

3、tronic 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美国食品与药品管理局fr final reportgcp good clinical practiceglpgood laboratory practicegmp good manufacturing practice ibinvestigator's brochureicinformed consenticfinformed consent

4、form总结报告药物临床试验质吊管理规范 药物if临床试验质杲管理规范 药品生产质量管理规范研究者手册知情同意idmidmciecindirbivdindependent data monitoring独立数据监察independent data monitoring committee 独立数据监察委员会 independent ethics committee独立伦理委员会investigational new drug新药临床研究institutional review board机构审查委员会in vitro diagnostic体外诊断知情同意书ichinternational co

5、nference on harmonization 国际协调会议ivrs interactive voice response system 耳动语音应答系统ma marketing approval/authorization 上市许可证mcamedicines control agencymhwministry of health and welfarendanew drug applicationnecnew drug entitynihnational institutes of health英国药品监督局日本卫生福利部新药巾请新化学实体国家卫牛研究所（美国）exclusion cri

6、teriainclusion criteria阳性对照、活性对照稽查稽查报告稍查员空口对照盲法/设盲病历临床研究临床试验临床试验报告依从性协调委员会交艾研究双盲终点指标必需文件排除标准入选农准plprincipal investigator主要研究者plproduct license产品许可证pmapre-market approval (application)上市前许可(申请)psistatisticians in the pharmaceutical industry 制药业统计学家协会qaquality assuranee质量保证qcquality control质量控制raregul

7、atory authorities监督管理部门sasite assessment现场评估saeserious adverse event严重不良事件sapstatistical analysis plan统计分析计划sarserious adverse reaction严乘不良反应sdsource data/document原始数据/文件sdsubject diary受试者日记sfdastate food and drug administration国家食品药品监督管理局sdvsource data verification原始数据核准selsubject enrollment log受试者

8、入选表sisub-i nvestigator助理研究者sispon sor-in vestigator申办研究者sicsubject identification code受试者识别代码sopstandard operating procedure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uaeun expected adverse eve nt预料外不良事件whoworld health organization世界卫生组织w

9、ho-icdra who international conference of drug regulatory authorities who 国际药品管理当局会议active controlauditaudit reportauditorblank controlblindin g/maskingcase historyclinical studyclinical trialclinical trial reportcompliancecoordinating committeecrossover studydouble blindingendpoint criteria/measurem

10、entessential documentationinformation gathering信息收集initial meeting启动会议in specti on检察/视察institution inspection机构检察investigational product试验药物investigator研究者monitor监查员（监察员）mon itori ng监查（监察）monitoring plan监查计划（监察计划）monitoring report监查报告（监察报吿）multi-center trial多中心试验non-clinical study非临床研究original medic

11、al record原始医疗记录outcome assessment结果评价patient file病人档案patient history病历placebo安慰剂placebo control安慰剂对照preclinical study临床前研究protocol试验方案protocol amendments修正案ran domizati on随机reference product参比制剂sample size样本量、样本大小serious ness严重性severity严重程度single blinding单盲sponsor巾办者study audit研究稽查subject受试者subject

12、enrollment受试者入选subject enrollment log受试者入选表subject identification code list受试者识别代码表subject recruitment受试者招募study site研究中心subject screening log受试者筛选表system audit系统稽查lest product受试制剂trial initial meeting试验启动会议trial master file试验总档案trial objective试验h的triple blinding三盲wash-out洗脱wash-out period洗脱期cal res

13、earch associateing, shanghai, guangzhou, wuhan, chengdu, shengshanges:tocol complianee, ich-gcp and other regulatory obligations at trial sites by standardized :tivities:curacy and authenticity of clin ical data, man age in vestigational products and other trial ies, maintain adequate clinical trial

14、 documentation etcitivities in line with milestones (i.e. startup, monitoring, closeout, etc.) in complianee with ds and ich-gcpj communication between sponsor and investigator, report related issues to the line nediatelytimely reporti ng of study information, which includes safety reporting to releva nt studyr and regulatory authoritieselated to clinical trial monitoringelor or above in medical or above, majoring in medicine or pharmacy or