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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2017, Vol. 22 ›› Issue (12): 1388-1393.

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

XU Xiaoyan1, LIU Yuxiu2   

  1. 1 School of Public Health,Nanjing Medical University, Nanjing 211166, Jiangsu, China; 2 Department of Medical Statistics, Jinling Clinical Medical College (Nanjing General Hospital), Nanjing Medical University, Nanjing 210002, Jiangsu, China
  • Received:2017-05-15 Revised:2017-05-31 Online:2017-12-26 Published:2018-01-02

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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

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