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r4subrisk  

Risk Quantification Engine for Clinical Submission Readiness
View on CRAN: Click here


Download and install r4subrisk package within the R console
Install from CRAN:
install.packages("r4subrisk")

Install from Github:
library("remotes")
install_github("cran/r4subrisk")

Install by package version:
library("remotes")
install_version("r4subrisk", "0.1.0")



Attach the package and use:
library("r4subrisk")
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 submission risk using a Failure Modes and Effects Analysis (FMEA)-inspired framework (probability, impact, detectability). Builds risk registers from evidence, computes Risk Priority Numbers (RPN), classifies risk levels, and emits standardized R4SUB (R for Regulatory Submission) evidence table rows via 'r4subcore'. Supports risk mitigation tracking and trend analysis across submission milestones.
How to cite:
Pawan Rama Mali (2026). r4subrisk: Risk Quantification Engine for Clinical Submission Readiness. R package version 0.1.0, https://cran.r-project.org/web/packages/r4subrisk. Accessed 04 Jul. 2026.
Previous versions and publish date:
No previous versions
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Complete documentation for r4subrisk
Functions, R codes and Examples using the r4subrisk R package
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