| Scope |
|---|
There is consensus across industry that software used for regulatory submission needs to be validated. However, there are few industry accepted guidelines on what is specifically required to meet the bar of validation for Open Source tools and user-contributed extensions, specifically R and R packages.There are two deliverables from this project: a White Paper and an R package. The White Paper will serve as a reference for industry on how to perform validation for user-contributed extensions of programming software. It will detail the elements that need to be met for the extension to be validated, and ways to document the process in a reusable, efficient, and sharable fashion. The R package will be developed to provide the tools and guidance for validating an R package. It will show how to take advantage of the tools that exist in the R language, and it will be based on the White Paper to ensure the baseline requirements are achieved.With these tools, there will be a standard to reference on how to approach validation of extensions to the R language. Additionally, by demonstrating how to perform validation, the framework can be more generally applied to software extensions in other languages. |
Project Lead | |
|---|---|
Eli Miller | ellishughes@live.com |
Key Milestones
| Objective | Timeline |
|---|---|
| Complete the Docker POC Project | Q4 2020 |
| Kick off the Docker pilot for a real submission | Q4 2020 |
White Paper on best practices for interactive analyses for decision making & submissions | Q4 2020 |
CURRENT STATUS
Continuing to write the White Paper, awaiting feedback from the FDA on the POC submission.
Project Members
| Name | Organisation |
|---|---|
Catherine Xiao | Gilead |
Douglas Warfield | Ireview |
Eric Herbel | Industry |
Gaoyang Li | Bayer |
Hari J Vardhan | Chiltern |
Iraj Mohebalian | Bayer |
Karl Brand | Bayer |
| Maria Dalton | GSK |
Mary Nilsson | Eli Lilly |
| Mominul Islam | Sarepta |
Nagadip Rao | Elissen |
Volunteer Today
Our project always welcomes new members to collaborate in an open, transparent and non-competitive project. If you are interested in joining please contact workinggroups@phuse.eu.