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Merge branch 'main' into 234-how-i-rebuilt-a-lost-ecg-data-script-in-r
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Vladyslav committed Oct 1, 2024
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1 change: 1 addition & 0 deletions inst/WORDLIST.txt
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Expand Up @@ -1120,3 +1120,4 @@ astrazeneca
laura
MeetLaura
needleman
WEL
2 changes: 1 addition & 1 deletion posts/2023-08-14_rhino_submission_2/rhino_submission_2.qmd
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Expand Up @@ -29,7 +29,7 @@ The [R Consortium Submissions Working Group](https://rconsortium.github.io/submi
This Pilot was completed on [March 10, 2022](https://github.com/RConsortium/submissions-wg/blob/main/_Documents/Summary_R_Pilot_Submission2.pdf) after a successful statistical review and evaluation by the FDA staff.

Moving forward, the [Pilot 2](https://rconsortium.github.io/submissions-wg/pilot2.html) aimed to include a Shiny application that the FDA staff could deploy on their own servers.
The R Consortium recently announced that [on September 27, 2023](https://www.r-consortium.org/announcement/2023/10/05/shiny-app-successfully-reviewed-by-fda-cder-staff-pilot-2-announcement-2), the R Submissions Working Group successfully completed the follow-up to the Pilot 2 R Shiny-based submission and received a response letter from FDA CDER. This marks the first publicly available submission package that includes a Shiny component.
The R Consortium recently announced that [on September 27, 2023](https://www.r-bloggers.com/2022/12/update-successful-r-based-package-submission-with-shiny-component-to-fda/), the R Submissions Working Group successfully completed the follow-up to the Pilot 2 R Shiny-based submission and received a response letter from FDA CDER. This marks the first publicly available submission package that includes a Shiny component.
The full FDA response letter can be found [here](https://github.com/RConsortium/submissions-wg/blob/0f1dc5c30985d413f75d196c2b6caa96231b26ee/_Documents/Summary_R_Pilot2_Submission%2027SEP2023.pdf).

The Shiny application that was sent for the Pilot 2 had the goal to display the 4 Tables, Listings and Figures (TLFs) that were sent for the Pilot 1 with basic filtering functionality. 
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Expand Up @@ -50,7 +50,7 @@ for particular connected networks such as our package maintainers, or those
teams powering pharmaverse-specifics such as our blog and website.
Additionally, for any wider open source industry challenges we would recommend
any would-be contributors towards
[PHUSE DVOST](https://advance.phuse.global/pages/viewpage.action?pageId=327777),
[PHUSE DVOST](https://advance.hub.phuse.global/wiki/spaces/WEL/pages/26804419/Data+Visualisation+Open+Source+Technology),
given our strong and continued partnership with PHUSE.

Note that the above does not impact the role of the pharmaverse council - all
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- [A Not So Short Introduction to rtables](https://waddella.github.io/RStudioTableContest2020/A_Not_So_Short_Introduction_to_rtables.html) 

- [Introduction to {rtables}](https://cran.r-project.org/web/packages/rtables/vignettes/introduction.html)
- [Introduction to {rtables}](https://insightsengineering.github.io/rtables/latest-release/articles/rtables.html?q=introduction)

- [GitHub - insightsengineering/rtables: Reporting tables with R](https://github.com/insightsengineering/rtables)  

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