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Metadata | SDTMs | ADaMs | References
D. Pharmaverse: Regulatory Submission Process Flow - Bookmark This Page!
Metadata > OAK > Admiral > Define.xml > TLGs (rtf/pdf) > Submissions > Shiny
R Package |
Metadata |
Raw to SDTMs |
To ADaMs |
To Tables, Lists and Graphs |
R Scripts (Tidyverse, DPLYR, etc.) |
N/A | R Scripts | R Scripts |
R Scripts: Statistical Analysis |
Pharmaverse |
rTables [TLGs] |
The pharmaceutical industy has quickly adapted to embrace R! The Pharmaverse concept is created as a collaboration amoung top pharma and industy organizatins for open-source solutions. Organizations now have the option to continue programming in R using common packages or use the packages from Pharmaverse to get a jump start. With Pharmaverse R package compliance standards, organizations can feel more confident to apply these packages. Smarter organizations make time to confirm packages behave as expected with expected results. Up to 50% of Pharmaverse is built using Tidyverse. This page is designed to help guide you using Pharmaverse packages.
Pharmaverse has R packages that work as modules to help in the CDISC submission process. Organizations can plan to understand and start to incoporate R packages as needed to grow. See new to clinical data and new to CDISC to learn about the basics. Note that the SDTMs and ADaMs pages within R-Guru utilize base R and other non-Pharmaverse packages.
label(df[["vr1"]]) <- "My Label" # data frame options method
intersect(names(df1), names(df2)) # list common variables between df1 and df2
Admiral (ADaM in R Asset Library) Package, Workflow, Datasets, Releases
Github - PhUSE, IQ-OQ [R Scripts]
PHUSE: Data Visualization and Open Source Technology [Site Resource]
Admiral - CDISC Open Source, Example
Roche: Shifting to an Open-Source Backbone in Clinical Trials [Video]
RStudio: Regulatory Compliance and Validation Issues [FDA, Updated Version]
R: Regulatory Compliance and Validation Issues A Guidance Document for the Use of R in Regulated Clinical Trial Environments [FDA, Pilot Project]
tidyverse, tidymodels, r-lib, and gt R packages: Regulatory Compliance and Validation Issues [FDA]
shiny and rmarkdown R packages: Regulatory Compliance and Validation Issues [FDA]
R: Software Development Life Cycle A Description of R’s Development, Testing, Release and Maintenance Processes [FDA, Validation]
Introduction to sendigR [Enable Cross-Study Analysis of CDISC SEND Datasets]
Get Started with {tidyCDISC} [Quick Table Generation & Exploratory Analyses on ADaM-Ish Datasets]
xportr [Utilities to Output CDISC SDTM/ADaM XPT Files]
envsetup [auto source files from full path folders]
Checklist for CRAN submissions [Auto tests]
Patient Profiles: Introduction, Template
Electronic common technical document submission with analysis using R
Auditing Open-source Software Framework in a Regulatory Environment: Challenges, Gaps and Recommendations, Shahrzad Talebian, Rafiq Furniturewala, Thomas Joseph Carpenter, Uday Preetham Palukuru [Presentation]
Revolutionizing SDTM Transformation in Pharma: Introducing {sdtm.oak} – An Open-Source R Package, Rammprasad Ganapathy, Susheel Arkala, Edgar Manukyan [Presentation]
{admiral} - from open source through to company implementation, Ross Farrugia [Presenation]
Exploring R Package Validation in Life Sciences: Appsilon's Collaboration with the R Validation Hub