中国临床药理学与治疗学2017，Vol.22Issue(11)：1248-1258,11.
基于SDTM define.xml元数据自动化检查的SAS宏实现
Automated inspection for SDTM define.xml based on metadata via SAS macro
朱欢 1刘玉秀 2于浩1
作者信息
- 1. 南京医科大学公共卫生学院,南京211166,江苏
- 2. 南京医科大学金陵临床医学院(南京军区南京总医院)医学统计学教研室,南京210002,江苏
- 折叠
摘要
Abstract
Nowadays,FDA has specifically established the rules of electronic review files for drug submission.SDTM define.xml,which is based on CDISC ODM (Operational Data Model),has been used as one of the essential documents for FDA review.In recent years many pharmaceutical and CRO companies devote themselves to developing tools to realize automated SDTM define.xml generation.But in terms of quality control,little research is carried out;therefore,people need to spend more time on manual check.The purpose of this research is to create a set of comprehensive checklist based on SDTM define.xml metadata,and realize automated inspection and quality control systematically for these checkpoints via SAS macro.As a result,to ensure all info in SDTM define.xml is correct and kept good traceability by decreasing the human cost and raise efficiency at the same time.关键词
FDA/CDISC/SDTM/define.xml/自动化检查/ODMKey words
FDA/CDISC/SDTM/define.xml/automated inspection/ODM分类
医药卫生引用本文复制引用
朱欢,刘玉秀,于浩..基于SDTM define.xml元数据自动化检查的SAS宏实现[J].中国临床药理学与治疗学,2017,22(11):1248-1258,11.
