Announcement

The R Consortium is pleased to announce that on August 28, 2023, the R Submissions Working Group successfully submitted an R-based test submission pilot 3 package through the FDA eCTD gateway! The FDA CDER staff are now able to begin their evaluation process. All submission materials can be found at: https://github.com/RConsortium/submissions-pilot3-adam-to-fda 

The pilot 3 test submission is an example of an all R submission package following eCTD specifications. These include the installation and loading of the proprietary {pilot3} R package and other open-source R packages, R scripts for the analysis data model (ADaM) datasets from pilot 3 and tables, listings, figures (TLFs) from pilot 1, analysis data reviewer’s guide (adrg), and other required eCTD components. To our knowledge, this is the first publicly available R-based FDA submission package, which includes R scripts to generate ADaM datasets and TLFs. We hope this submission package and our learnings can serve as a good reference for future R-based regulatory submissions from different sponsors. Additional agency feedback will be shared in future communications.  For any future questions, you may contact the pilot 3 team here: https://rconsortium.github.io/submissions-pilot3-adam/main/index.html.

The working group also began working on a pilot 4 project to explore the use of novel technologies such as Linux containers and WebAssembly software to bundle a Shiny application into a self-contained package in order to facilitate a smoother process for transferring and executing the application. Stay tuned for more about pilot 4 in the future.

For past announcements on pilot 1 and pilot 2, see below.

Announcement of the R Consortium R submission pilot 1:

Announcement of the R Consortium R submission pilot 2, an R based test submission with a shiny component:

https://www.r-consortium.org/blog/2022/12/07/update-successful-r-based-package-submission-with-shiny-component-to-fda

About the R consortium R submission working group

The R Consortium R Submissions Working Group is focused on improving practices for R-based clinical trial regulatory submissions.

To bring an experimental clinical product to market, electronic submission of data, computer programs, and relevant documentation is required by health authority agencies from different countries. In the past, submissions have been mainly based on the SAS language. 

In recent years, the use of open source languages, especially the R language, has become very popular in the pharmaceutical industry and research institutions. Although the health authorities accept submissions based on open source programming languages, sponsors may be hesitant to conduct submissions using open source languages due to a lack of working examples.

Therefore, the R Consortium R Submissions Working Group aims at providing R-based submission examples and identifying potential gaps during submission of these example packages. All materials, including submission examples and communications, are publicly available on the R consortium Github page: https://github.com/RConsortium.

The R consortium R submission working group includes members from more than 10 pharmaceutical companies, as well as regulatory agencies. More details of the working group can be found at: https://rconsortium.github.io/submissions-wg/.

The R consortium R submission working group is open to anyone who is interested in joining. If interested, please contact Joseph Rickert at joseph.rickert@gmail.com. 

Motivated by the growth of the R Consortium over the past several years and the expansion of activities, the R Consortium Board of Directors has taken a step to ensure long-term, consistent oversight of day-to-day activities. 

The R Consortium is pleased to announce that Joseph Rickert has been appointed to the position of Executive Director reporting directly to the Board of Directors.

Joseph has been active in the R Community since he joined Revolution Analytics in 2009 and has held prominent, community-facing positions at both the R Consortium and RStudio (now renamed posit). He is deeply involved in multiple R Consortium technical working groups, is an organizer of the Bay Area useR Group (BARUG), and has been on the R/Medicine conference organizing committee since the first conference in 2018. Joseph served on the R Consortium Board of Directors from August 2016 to July 2023, serving as Chair from 2020.

Welcome, Joseph, to your new position!

After serving as chair of the board for the R Consortium and being involved in multiple R Consortium committees both on the technical and community development sides, as well as participating directly in R-focused events, webinars, and countless other R activities, Joseph Rickert is stepping away from the position. The board will be conducting elections to decide the next chair.

Joseph has been with the R Consortium since it was first conceived in 2014.  His initial role was as Community Officer. In 2018, he began to also serve as Secretary. In 2019, he was elected chair of the board. 

Thank you for your tireless interest in promoting R and supporting developers and user groups around the world who are working to improve the R programming language.

Thank you, Joseph!

Back in 2018, when I was most involved in developing choroplethr, Joe Rickert, R Consortium Director, recommended that I submit a proposal to the R Consortium to create a Working Group related to Census data. I was intrigued to see what a group like that could accomplish and submitted a proposal. The proposal was accepted, and the group’s main accomplishment was publishing A Guide to Working with Census Data in R. After publishing the Guide, however, the group went dormant.

Fast forward 5 years, and last month I published a new package related to Census data: zctaCrosswalk. When discussing the package with Joe he mentioned that he recently spoke to some leaders at Census who were interested in revitalizing the R Consortium Census Working Group. He asked me if I was interested in meeting the people who were interested, and of course I said yes!

We just had a preliminary meeting, and several exciting ideas were discussed. One is to write a new version of ‘A Guide to Working with Census Data in R.’ We are still in the early stages of deciding what a new version might look like, but one goal would be to remove links to deprecated software such as American FactFinder. More broadly, the original guide was written as a survey of both Census data and CRAN packages. Perhaps the Guide might be more useful if it was written more as a tutorial to the most popular datasets and packages.

We also discussed ideas for longer-term projects. For example, applying for funding from the R Consortium, and directing that funding towards the development of R packages that might improve the R ecosystem for Census data.

If you have an interest in following our work or participating in our next meeting, please sign up below.

The R Consortium has begun the disbursement of grants to help R User Groups (RUGS) around the world organize, share information, and support each other. We are currently accepting applications until September 30, 2023! 

With these grants, the R Consortium looks forward to facilitating and supporting the person-to-person exchange of knowledge in small group settings on a global scale. RUGS grants are intended to help people form enduring R user group communities. The RUGS program is supporting both virtual and in-person events.

In 2023, the three categories for RUGS Program grants:

1. User Group Grants
2. Conference Grants
3. Special Project Grants

🏆 Highlighting R-Ladies São Paulo, in Brazil

Beatriz Milz, teacher at Curso R, Ph.D. Student in Environmental Science, and co-organizer of R-Ladies São Paulo, recently received a grant from the R Consortium. The grant was requested to help facilitate R-Ladies São Paulo Meetups which host 40-50 people per meeting. The Group intends to use the funds to continue to host events for locals of the São Paulo area. With the funds provided, the group has been able to offer transportation assistance for low-income participants that otherwise can’t come to the event, children caretaker per event, R Swag, snacks, and team apparel. The group hopes to continue with its momentum and offer more meetups to new and experienced R users.

In these Meetups, R-Ladies São Paulo organizes different talks and trainings including some of their most recent ones:

• Meetup R-Ladies São Paulo – Open Data Analysis with R – Open Data Day
  • Blog by Beatriz and other co-organizers: An event part of the Open Data Day initiative (in English)
    • Highlights: Childcare and  the Gugudadados Space👩‍🍼, Collaborative coffee 🥮☕, and Saving a percentage of spots for other minorities 
• [Online Meetup] Data Science, Gender and Race in Public Policy
  • Materials and video (in Portuguese): https://rladies-sp.org/eventos/2023-05-20/

Upcoming event: Saturday, June 24, 2023, at 12:00 PM PT (GMT-3) / 8 AM PT

The next event will be a full-day meetup with an Introduction to R and Tidyverse. 

The slides and materials (in Portuguese) are available in: https://r-ladies-sao-paulo.github.io/2023-06-oficina-introducao-R/slides.html

Meetup R-Ladies São Paulo – Oficina de Introdução ao R e ao Tidyverse 

Check out the group’s Meetup, R-Ladies São Paulo 

Blog: https://rladies-sp.org/

Follow them on Social media! 

Instagram: https://www.instagram.com/RLadiesSaoPaulo/

Twitter: https://twitter.com/rladiessaopaulo 

Linkedin: https://www.linkedin.com/company/r-ladies-sao-paulo/

Youtube: https://www.youtube.com/c/RLadiesS%C3%A3oPaulo/videos

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Get Involved!

The 2023 RUGS Program is currently taking applications and will close at midnight PST on September 30, 2023. 

These grants do not include support for software development or technical projects. Grants to support the R ecosystem’s technical infrastructure are awarded and administered through the ISC Grant Program which issues a call for proposals two times each year.

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The R Consortium gives grants to help R User Groups (RUGS) around the world organize, share information, and support each other. We are currently accepting applications! 

The R Consortium RUGS Program has grown from being a relatively modest R user group support program to being the primary vehicle for the R Consortium to award Social Infrastructure Grants. Social Infrastructure includes meetings, events, conferences and any other activity intended to strengthen the social, organizational, and identity structures of the R Community. 

In 2023, there will be three categories of RUGS Program grants:

1. User Group Grants
   1. The intent of user group grants is to facilitate person-to-person exchange of R knowledge in small group settings on a global scale.
   2. Cash grants typically vary between $200 and $1,000 and depend on group size and special needs.
   3. All groups who are accepted into the RUGS program who are not already participating in the R-Ladies Meetup.com Professional Account program are enrolled in the RUGS program which covers Meetup.com dues.
2. Conference Grants
   1. To qualify for a RUGS program conference grant, an event must be focused on the R language and offer at least one full day of technical talks and presentations and aim to attract participants with diverse backgrounds. These grants are for conferences organized by non-profit or volunteer groups.
3. Special Project Grants
   1. With our Special Projects Grants categories, we hope to stimulate the imagination of local R community builders. 

Full details here: https://www.r-consortium.org/all-projects/r-user-group-support-program. Please help support R language. Submit your proposals!

R User Groups

There are currently 98 R User Groups (RUGS) organizing and learning and spreading the use of R globally. These groups welcome individuals from any background, from beginner-level users to experts. 

Check out our recent blog interviews by organizers of the R User Groups across all industries:

Get Involved!

The 2023 RUGS Program is currently taking applications and will close at midnight PST on September 30, 2023. 

These grants do not include support for software development or technical projects. Grants to support the R ecosystem’s technical infrastructure are awarded and administered through the ISC Grant Program which issues a call for proposals two times each year.