The defineR package is an open-source R language package to create define.xml documents that are suitable for submission to the U.S. Food and Drug Administration. The package has the following capabilities:

1. Create the define.xml document
2. Perform consistency checks and schema validation of the define.xml
3. Write and view a report of the consistency checks
4. Produce the define.html transformation of define.xml
5. Generate the metadata templates needed to create the define.xml

Currently, the package only supports version 2.0.0 of the define.xml for SDTM and ADaM. Future enhancements to the package will add support for define version 2.1.

IMPORTANT: This package is being released experimentally for the purposes of gathering public feedback. It is not recommended to use this package for regulatory submissions yet. Please do use this package to examine and refine your metadata, scrutinize the output, and submit any issues/suggestions to the GitHub issue list here.

The easiest way to install the defineR package is to run the following command from your R console:

install.packages("defineR")

Then put the following line at the top of your script:

library(defineR)

For examples and usage information, please visit the defineR documentation site here

If you need help, the first place to turn to is the defineR web site.

If you want to look at the code for the defineR package, visit the github page here.

If you encounter a bug or have a feature request, please submit an issue here.

The defineR package is associated with the sassy meta-package, and utilizes many of the packages from that system. The sassy meta-package includes several packages that help make R easier. You can read more about the sassy packages here.