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r4subtrace  

Traceability Engine for Clinical Submission Readiness
View on CRAN: Click here


Download and install r4subtrace package within the R console
Install from CRAN:
install.packages("r4subtrace")

Install from Github:
library("remotes")
install_github("cran/r4subtrace")

Install by package version:
library("remotes")
install_version("r4subtrace", "0.1.0")



Attach the package and use:
library("r4subtrace")
Maintained by
Pawan Rama Mali
[Scholar Profile | Author Map]
All associated links for this package
First Published: 2026-03-03
Latest Update: 2026-03-03
Description:
Quantifies and explains end-to-end traceability between clinical submission artifacts (ADaM (Analysis Data Model) outputs, derivations, SDTM (Study Data Tabulation Model) sources, specs, code). Builds trace models from metadata and mapping sheets, computes trace levels, and emits standardized R4SUB (R for Regulatory Submission) evidence table rows via 'r4subcore'.
How to cite:
Pawan Rama Mali (2026). r4subtrace: Traceability Engine for Clinical Submission Readiness. R package version 0.1.0, https://cran.r-project.org/web/packages/r4subtrace. Accessed 29 Aug. 2026.
Previous versions and publish date:
No previous versions
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Complete documentation for r4subtrace
Functions, R codes and Examples using the r4subtrace R package
Full r4subtrace package functions and examples
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