临床试验相关常用英文缩写

CRA相关常用英文缩写CRA:Clinical Research Associate临床研究监察员，临床研究助理CRO:Contract Research Organization合同研究组织TTP:time-to-progression疾病进展时间SAE:severity Adverse Event严重不良事件AE:Adverse Event不良事件SOP:Standard Operating Procedure标准操作规程CRF:Case Report form病例报告表DLT:Dose limting toxicity剂量限制毒性MTD:maximal tolerable dose最大耐受剂量KPS:Kamofsky Performance Status行为状态评分CR:complete response完全缓解PR:partial response部分缓解SD:stable disease病情稳定PD:progressive disease病情进展IEC:independent ethics committee独立伦理委员会IRBinstitutional review board伦理委员会DFS:Disease Free Survival无病生存期OS:(Overall Survival)总生存时间1C:nformed consent知情同意ADR:Adverse Drug Reaction不良反应GAP:Good Agricultural Practice中药材种植管理规范GCP:Good Clinical Practice药物临床试验质量管理规范GLP:Good Laboratory Practice药品实验室管理规范GMP:Good Manufacturing Practice药品生产质量管理规范GSP:Good Supply Practice药品经营质量管理规范GUP:Good Use Practice药品使用质量管理规范PIPrincipal investigator主要研究者CI:Co-inveatigator合作研究者SISub-investigator助理研究者COICoordinating investigtor协调研究者ICF:Informed consent form知情同意书ICH:Intennational Conference on Hamonization of Technical Requirements for Registrationof Pharmaceuticals([,fc:ma'sju:tikalz]医药品)for Human Use人用药物注册技术要求国际协调会议RCT:randomized controlled trial,.随机对照试验NRCCT:non-randomized concurrent controlled trial,非随机同期对照试验([ken'kArent]区concurrent adj.同时发生的)EBM:evidence-based medicine循证医学HCT:historial control trial,历史对照研究RECIST:Response Evaluation Criteria In Solid Tumors.实体瘤疗效反应的评价标准