ADaM提交评审材料的核查路径及SAS宏实现

Checkpoint checklist for ADaM submission package and SAS Macros for package validation

FDA对于新药申报递交材料的要求有明确规定,并强制要求凡是满足电子递交的项目必须使用临床数据交换标准协会(Clinical Data Interchange Standards Consortium,CDISC)标准。递交评审材料内容繁琐,给递交机构和人员带来了很大的挑战,需要花费大量时间来进行内容的核查。本文将在对CDISC标准中分析数据模型(ADaM)递交评审材料进行系统分析的基础上,建立明确的关键核查点,针对核查内容形成相关的核查路径,并借助SAS宏功能实现自动化核查,减少人工核查的成本,为提升ADaM电子递交评审材料的质量和效率提供有效手段。

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.