关键词: FDA , CDISC , SDTM , define.xml , 自动化检查 , ODM

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.  

Key words: FDA, CDISC, SDTM, define.xml, automated inspection, ODM