Checkpoint checklist for ADaM submission package and SAS Macros for package validation
- VernacularTitle:ADaM提交评审材料的核查路径及SAS宏实现
- Author:
Xiaoyan XU
1
;
Yuxiu LIU
Author Information
1. 南京医科大学公共卫生学院,南京211166,江苏
- Keywords:
FDA submission package;
CDISC standard;
define.xml;
XML Mapper;
SAS macros
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2017;22(12):1388-1393
- CountryChina
- Language:Chinese
-
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.
