基于CDISC标准的病例报告表注释流程及方法

Process and method for CDISC-based CRF annotation

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: A CDASH-based CRF annotation plays an important role in database setup and data verification. The STDM-based CRF annotation is also one of the essential documents when the package of clinical trial data is submitted to the regulatory authority. This paper describes the contents, procedures and related stipulations used in the CDISC-based CRF annotation.