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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 

(Create Random ADaMs)

To Tables, Lists and Graphs 
 

R Scripts

(Tidyverse, DPLYR, etc.)

 N/A R Scripts  R Scripts 

R Scripts: Statistical Analysis

Tables & Lists, Graphs 

R Markdown

R Shiny

 

Pharmaverse

Blog

Metacore 

[ExamplesStructureFunctions]

Metatools

OAK [PresentationGithub]

SDTMChecks

[Example, FunctionsVideo 1, Video 2Github]

ADMIRAL 

[VideoStepsGithub]

rTables [TLGs

Tpylr


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. 

Pharmaverse Common FAQs - Your Guide to Leveraging Pharmaverse Packages
  • Where do you start? What is your task/objective?
    • As pharmaverse continues to grow, there are packages for the full clinical trial workflow process:
    • Metadata > OAK > Admiral > Define.xml > TLGs (rtf/pdf) > Submissions > Shiny
  • Who are the key players?
    • Pharma industry leaders setting ‘new standards in R and submissions’ since they are key developers of pharmaverse packages
    • Genentech, GSK, Merk, J&J
    • CDISC
    • PHUSE, Atorus, Appsilon, ProCogia
  • Do you have to use all of the pharmaverse packages?
    • No, organizations can choose and priority packages to test and install
    • Organizations can continue to use tidyverse and dplyr for in-house developed R scripts
  • How different are pharmaverse packages to tidyverse?
    • Pharmaverse packages are built from up to 50% of tidyverse packages so can easily learn pharmaverse packages
  • What methods can I learn and apply pharmaverse packages?
    • R-Guru.com/pharma is a designed for the collecdtion and curation of:
    • Videos
    • Examples
    • Case Studies
    • Documentation
  • What about pharmaverse shiny apps?
  • Why should i use pharmaverse packages?
    • Organizations can save development time, money and SMEs
  • Are there risks in using pharmaverse packages?
    • Yes, organizations are responsible for their own risk management
    • Pharmaverse packages undergo rigorous tests to help assure robust and reliable results





  • # Metadata functions: contents(), names(), rename(), label(), contains(), starts_with(), ends_with(), nchar()

  • print(contents(df), maxlevels=10, levelType='table') # requires hmisc package

  • names(adsl) <- tolower(names(adsl)) # lower case all variable names, toupper()

  • df <- df %>% rename(vr_new = vr_old) # rename variables

  • label(df$vr1) <- 'My Label' # assign variable labels
  • label(df[["vr1"]]) <- "My Label" # data frame options method

  • attr(data[["age"]], "label")  attr function to assign labels

  • df2 <- df1 %>% select(-contains('vr1')) # drop variables names that contain vr1

  • df <- select (vr1, vr10:vr15, starts_with("L")) # select vr1, vr10 to vr15 variables by order and variables that start with L, ends_with() 

  • intersect(names(df1), names(df2)) # list common variables between df1 and df2


  • setdiff(names(df1), names(df2)) # list of df1 unique variables that are not in df2

  • nms <- c(names(df1), names(df2)) # list of unique variable names from two or more data frames to compare
  • nms[duplicated(nms)] 


    SDTM Checks: Documentation, ExamplesFAQs


    Admiral (ADaM in R Asset Library) Package, WorkflowDatasets, Releases



    Pharmaverse TLGs


       

           

                  

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