Electronic common technical document submission with analysis using R.

pkglite and the proposed workflow enable the sponsor to submit well-organized R scripts following the electronic common technical document specification. The workflow has been used in the first publicly available R-based submission to the US Food and Drug Administration by the R Consortium R submission working group (https://www.r-consortium.org/blog/2022/03/16/update-successful-r-based-test-package-submitted-to-fda).