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r4subdata  

Example Datasets for Clinical Submission Readiness
View on CRAN: Click here


Download and install r4subdata package within the R console
Install from CRAN:
install.packages("r4subdata")

Install from Github:
library("remotes")
install_github("cran/r4subdata")

Install by package version:
library("remotes")
install_version("r4subdata", "0.1.0")



Attach the package and use:
library("r4subdata")
Maintained by
Pawan Rama Mali
[Scholar Profile | Author Map]
All associated links for this package
First Published: 2026-02-20
Latest Update: 2026-02-20
Description:
Provides realistic synthetic example datasets for the R4SUB (R for Regulatory Submission) ecosystem. Includes a pharma study evidence table, ADaM (Analysis Data Model) and SDTM (Study Data Tabulation Model) metadata following CDISC (Clinical Data Interchange Standards Consortium) conventions (<https://www.cdisc.org>), traceability mappings, a risk register based on ICH (International Council for Harmonisation) Q9 quality risk management principles (<https://www.ich.org/page/quality-guidelines>), and regulatory indicator definitions. Designed for demos, vignettes, and package testing.
How to cite:
Pawan Rama Mali (2026). r4subdata: Example Datasets for Clinical Submission Readiness. R package version 0.1.0, https://cran.r-project.org/web/packages/r4subdata. Accessed 21 Aug. 2026.
Previous versions and publish date:
(2026-07-09 06:47), 0.1.0 (2026-02-20 12:40)
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Complete documentation for r4subdata
Functions, R codes and Examples using the r4subdata R package
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