Abstract: Providing a Study Data Reviewer's Guide for Clinical Data to accompany the SDTM datasets, define.xml, and annotated CRF in a submission gives additional information to help the FDA review team. The guide is traditionally authored using MS Word - a 100% manual and labor intensive process with its inherent shortcomings often exposed and aggravated during the usually frenzied sponsor submission process. R offers a more efficient solution with greater reproducibility: Programmatic document generation facilitated by Shiny and R Markdown. Shiny not only manages R Markdown knitting but gives the sponsor staff, who oftentimes are unfamiliar with R, the ability to quickly leverage R with just a crash course in Markdown. An example of applying Shiny and R Markdown to generate the Study Data Reviewer's Guide for Clinical Data will be presented.
Speaker: Mark Rothe
Affiliation: Sanofi
Title: Shinytized R Markdown: A Potent OTC Alternative to 1,3,7-Trimethylxanthine & Currently Indicated for NDA Document Generation, Among Others
Abstract_Sanitzed: Providing a Study Data Reviewer's Guide for Clinical Data to accompany the SDTM datasets, define.xml, and annotated CRF in a submission gives additional information to help the FDA review team. The guide is traditionally authored using MS Word - a 100% manual and labor intensive process with its inherent shortcomings often exposed and aggravated during the usually frenzied sponsor submission process. R offers a more efficient solution with greater reproducibility Programmatic document generation facilitated by Shiny and R Markdown. Shiny not only manages R Markdown knitting but gives the sponsor staff, who oftentimes are unfamiliar with R, the ability to quickly leverage R with just a crash course in Markdown. An example of applying Shiny and R Markdown to generate the Study Data Reviewer's Guide for Clinical Data will be presented.