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_r_val_hub_workstream_updates.qmd
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# 📜 Workstream Updates {transition="slide-in none"}
## 🗝 Key Policy Updates!
- R Submissions Working group Pioneering use of Containers for delivering
study analysis with positive health authority feedback.[^pharmasug]
### Reminder: News within the last year
- The FDA appears to accept `.R` files through their eSUB portal[^esub].
- The FDA has released a draft of a new _Computer Software Assurance[^csa]_ guideline
that seems to be increasingly the basis for their evaluation of R.
[^pharmasug]: [PharmaSUG 2024 #SS-376](https://www.pharmasug.org/us/2024/papers.html#SS-376)
[^esub]: [R Consortium R Submission WG, Pilot #1](https://github.com/RConsortium/submissions-pilot1)
[^csa]: [_Computer Software Assurance for Production and Quality Systems Software: Draft Guidance for Industry and Food and Drug Administration Staff_](https://www.fda.gov/media/161521/download)
# 📣 Communications Workstream
## Community Meetings 📆
### Past meetups...
- Jun 27, 2023 - *Learnings & Reflections from Case Studies* ([GitHub](https://github.com/pharmaR/events/tree/main/community_meetings/2023-06-27)/[slides](https://github.com/pharmaR/events/blob/main/community_meetings/2023-06-27/community_mtg_6_27_2023.pdf))
- Aug 09, 2023 - *Risk Metric Application and Risk Score – A 2-part Mini Series* ([GitHub](https://github.com/pharmaR/events/tree/main/community_meetings/2023-08-09_riskmetric_riskassessment_series))
- Nov 28, 2023 - *Wrapping Up 2023 and Welcoming 2024* ([slides](https://docs.google.com/presentation/d/1iq2HzcjVYGnR5sf-rgLZzxnGwMnrDlJJNJmziwfX3j0/edit#slide=id.g1e185ace86d_0_153)/[recording](https://www.youtube.com/watch?v=_r5x-baN76E&t=3s))
- Feb 03, 2024 - *Unraveling the Term “Validation”* ([GitHub](https://github.com/pharmaR/events/tree/main/community_meetings/2024-02-20)/[slides](https://github.com/pharmaR/events/blob/main/community_meetings/2024-02-20/RvalHub_2024Feb_Community_meeting.pdf)/[notes](https://github.com/pharmaR/events/blob/main/community_meetings/2024-02-20/RvalHub_2024Feb_Community_meeting_notes.txt))
- May 21, 2024 - *Tackling Hurdles: Embracing Open-Source Packages in Projects* ([GitHub](https://github.com/pharmaR/events/tree/main/community_meetings/2024-05-21)/[slides](https://github.com/pharmaR/events/blob/main/community_meetings/2024-05-21/RvalHub_2024May_Community_meeting.pdf/[notes](https://github.com/pharmaR/events/blob/main/community_meetings/2024-05-21/21MAY2024_community_meeting_notes.md))
<br>
### How do I sign up?
- ✉ Join our [mailing list](https://lists.r-consortium.org/g/RConsortium-Validation-Hub)!
- Follow the [R Consortium's Linkedin](https://www.linkedin.com/company/r-consortium/posts/)
## Our Next Community Meeting
:::: {.columns}
::: {.column width="30%"}
{height="7.4em" style="margin-left:50px"}
:::
::: {.column width="45%"}
<br>
🗓️ Tues, Aug 20, 2024
👩🦰 Bríd Roberts
⌨️ Novartis
:::
::::
### Analyzing change in assessed risk across package releases
> The Software Open Source (SOS) team manages and executes the risk assessment process for R package validation at Novartis. The team uses an internally developed R package to classify the risk of each package as "low", "medium", or "high".
>
> We analysed the risk assessment data over two time points to determine the impact on the assigned risk categorisation for packages with AND without version changes.
>
> In this talk, we showcase the risk assessments over time, the causes of any risk class changes, and their impact on various teams within our organizations as a result.
## Website Refresh: Then
## Website Refresh: Now
## Case Studies Refresh
## Gathering Package Lists
# {height="1.8em" width="1.8em" style="margin: 0 0.2em; object-fit: contain;vertical-align: middle;"} `{riskassessment}` App
## {height="1.8em" width="1.8em" style="margin: 0 0.2em; object-fit: contain;vertical-align: middle;"} `{riskassessment}` App
### Latest Features Recap
* Expanded decision automation to include individual {riskmetric} assessment values
* New `Function Explorer` page and faster exploration of source code
* Expanded the package dependency view
* Miscellaneous items
The feedback loop is crucial! All of these improvements started off as community-driven suggestions on our GitHub repo. If you have an idea that doesn't already exist on the [existing list](https://github.com/pharmaR/riskassessment/issues) of issues, [submit a new issue](https://github.com/pharmaR/riskassessment/issues/new) today and it may become a reality tomorrow.
## {height="1.8em" width="1.8em" style="margin: 0 0.2em; object-fit: contain;vertical-align: middle;"} `{riskassessment}` App
### Test drive now
TODO: add link and icon for small car
https://app.pharmar.org/riskassessment/
Looking for Volunteer "Leads" to represent
## {height="1.8em" width="1.8em" style="margin: 0 0.2em; object-fit: contain;vertical-align: middle;"} `{riskassessment}` App
### Decision Automation Rules, by metric assessment
## {height="1.8em" width="1.8em" style="margin: 0 0.2em; object-fit: contain;vertical-align: middle;"} `{riskassessment}` App
### New Function Explorer! (Code provided by _GSK_)
{.r-stretch .center style="display: block; margin: auto;"}
## {height="1.8em" width="1.8em" style="margin: 0 0.2em; object-fit: contain;vertical-align: middle;"} `{riskassessment}` App
### Package Dependency Integration
# {height="1.8em" width="1.8em" style="margin: 0 0.2em; object-fit: contain;vertical-align: middle;"} `{riskmetric}`
## {height="1.8em" width="1.8em" style="margin: 0 0.2em; object-fit: contain;vertical-align: middle;"} `{riskmetric}` Roadmap
### Big changes
Running from risk scores & focusing solely on metric assessments
::: { style="font-size:0.8em" }
- **Ease of use:**
Wrapper functions for a a complete workflow, prettier outputs
- **Metric completeness:**
Implement metrics for as many pacakge sources as possible. Chain sources
together to create more complete assessments
- **Modular additions:**
Allow users to easy add custom assessments, create optional assessments
based on community packages (e.g. `oyster`, `srr`, `pkgstats`, etc)
- **Focusing on metrics and scoring:**
Making custom weighting more robust and convenient. Guidance materials on
weighting specific assessments based on community feedback and our own views
on best practices.
:::