The primary purpose of this paper is to first lay out a process of generating a simplified Transport (.xpt) file with RStudio and Python to meet study electronic data submission requirements of the Food & Drug Administration (FDA). The second purpose of this paper is to compare the .xpt files created from three different languages: R, Python and SAS. The paper is the expansion of the original FDA guideline document “CREATING SIMPLIFIED TS.XPT FILES”, published in November, 2019.
Transport files can be created by SAS, as well as open source software, including R and Python. According to the FDA guideline document mentioned above, .xpt files can be created by R and Python. This may allow Pharmaceutical companies to expand use of R and Python beyond data visualization and statistical analysis currently being generated by these two languages. Hopefully, readers can use the process shown in the paper as a template to create .xpt files.
Watch Generating .XPT Files With SAS®, R and Python as presented by the authors on the SAS Users channel on YouTube.
This paper and video includes these topics and examples. Please watch the video and review the attached paper for details.
1) Using SAS to generate final datasets in .xpt format
2) Using RStudio to generate final datasets in xpt format
3) Using Python to generate final datasets in .xpt format
4) Review and Compare generated ts.xpt file in SAS Universal Viewer
CREATING SIMPLIFIED TS.XPT FILES
Study Data Technical Conformance Guide_v4.5
Technical Rejection Criteria for Study Data
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