【摘要】：在建立數(shù)據(jù)庫和數(shù)據(jù)核查時,依據(jù)臨床數(shù)據(jù)獲取協(xié)調(diào)標(biāo)準(zhǔn)(clinical data acquisition standards harmonization,CDASH)的病歷報告表(case report form,CRF)注釋具有重要的指導(dǎo)意義,而且臨床試驗(yàn)結(jié)果在申報給監(jiān)管當(dāng)局審閱時,基于研究數(shù)據(jù)制表標(biāo)準(zhǔn)(study data tabulation model,SDTM)的CRF注釋也是必不可少的文件之一。本文就基于臨床數(shù)據(jù)交換標(biāo)準(zhǔn)協(xié)會(clinical data interchange standards consortium,CDISC)標(biāo)準(zhǔn)的CRF注釋的內(nèi)容、流程和相關(guān)規(guī)定等方面進(jìn)行闡述。
[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.
【作者單位】： 科文斯醫(yī)藥研發(fā)(北京)有限公司;北京科林利康醫(yī)學(xué)研究有限公司;
【分類號】：R95
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本文編號：2353051