关键词: FDA提交评审材料, CDISC标准, define.xml, XML Mapper, SAS 宏

Abstract:

FDA clearly provides the rules for drug submission and requires that all the studies which are suitable in electronic format should follow CDISC standard. Due to the detailed contents of submission package, it's always a big challenge to submission institution and staff. It usually costs a lot of time for company or member to complete the validation before submission to FDA. Based on the ADaM submission package, this paper gives a clear picture of validation checkpoint checklist. For every checkpoint, it will see and find the ways to automatically validate through SAS macros or tools. So that it will decrease the manual checking workload, saving the time and shorten the submission period. 

Key words: FDA submission package, CDISC standard, define.xml, XML Mapper, SAS macros