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faq.qmd
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---
title: "Q & A"
---
## About R based regulatory submission
1. How to submit readable code in R to submit to the FDA?
- Readable code can be submitted as .r files, according to the [R consortium R submission working group pilot 1](https://github.com/RConsortium/submissions-pilot1-to-fda).
- Analytical codes using functions in open-sourced or proprietary packages are considered readable, as long as the proprietary R packages are submitted in the way as mentioned below.
2. How to submit proprietary R packages to FDA?
- Proprietary packages cannot be submitted as a compressed file through the eCTD gateway.
- However, proprietary R packages can be converted to a plain `.txt` file by [pkglite](https://merck.github.io/pkglite/) then submitted through the eCTD gateway. FDA reviewers can use the same package to convert the `.txt` file back to R package. An example can be found in the [R consortium R submission working group pilot 1](https://github.com/RConsortium/submissions-pilot1-to-fda).
3. What if open sourced R packages are used?
- No need to submit source code of open source packages.
- In adrg/programtoc, include package version, its dependency packages and their versions
- In analytical code, include appropriate `library()` calls.
4. If R is used, what is needed for the ADRG?
- If you use R it is recommended to have a section in the ADRG/programtoc that provides the FDA with:
- R version
- Package dependencies and their versions
- Instructions to convert proprietary R package `.txt` files back to the natural format (if proprietary R packages are submitted)
## About the R consortium R submission working group
1. Who can join the working group? How can I get involved?
- anyone can join the working group. The working group meets monthly on Friday. If you are interested in joining the monthly meetings, please contact Joe Rickert at joseph.rickert@rstudio.com.
- You can also monitor our [issue board](https://github.com/RConsortium/submissions-wg/issues). Any contribution/feedback are more than welcome