基于CDISC标准的病例报告表注释流程及方法
发布时间：2018-11-24 08:57
【摘要】：在建立数据库和数据核查时,依据临床数据获取协调标准(clinical data acquisition standards harmonization,CDASH)的病历报告表(case report form,CRF)注释具有重要的指导意义,而且临床试验结果在申报给监管当局审阅时,基于研究数据制表标准(study data tabulation model,SDTM)的CRF注释也是必不可少的文件之一。本文就基于临床数据交换标准协会(clinical data interchange standards consortium,CDISC)标准的CRF注释的内容、流程和相关规定等方面进行阐述。
[Abstract]:In the establishment of database and data verification, the annotation of the medical record report table (case report form,CRF) based on the clinical data acquisition coordination standard (clinical data acquisition standards harmonization,CDASH) has important guiding significance. And when clinical trial results are reported to regulators, CRF annotations based on the research data tabulation standard (study data tabulation model,SDTM) are one of the essential documents. This paper describes the content, process and related regulations of the CRF annotation based on the (clinical data interchange standards consortium,CDISC standard of the Association of Clinical data Exchange Standards.
【作者单位】： 科文斯医药研发(北京)有限公司;北京科林利康医学研究有限公司;
【分类号】：R95
，
本文编号：2353051
[Abstract]:In the establishment of database and data verification, the annotation of the medical record report table (case report form,CRF) based on the clinical data acquisition coordination standard (clinical data acquisition standards harmonization,CDASH) has important guiding significance. And when clinical trial results are reported to regulators, CRF annotations based on the research data tabulation standard (study data tabulation model,SDTM) are one of the essential documents. This paper describes the content, process and related regulations of the CRF annotation based on the (clinical data interchange standards consortium,CDISC standard of the Association of Clinical data Exchange Standards.
【作者单位】： 科文斯医药研发(北京)有限公司;北京科林利康医学研究有限公司;
【分类号】：R95
，
本文编号：2353051
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