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r4subrisk: Risk Quantification Engine for Clinical Submission Readiness

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.

Version: 0.1.0
Depends: R (≥ 4.2)
Imports: cli, dplyr, r4subcore, rlang, tibble
Suggests: testthat (≥ 3.0.0)
Published: 2026-03-03
DOI: 10.32614/CRAN.package.r4subrisk (may not be active yet)
Author: Pawan Rama Mali [aut, cre, cph]
Maintainer: Pawan Rama Mali <prm at outlook.in>
BugReports: https://github.com/R4SUB/r4subrisk/issues
License: MIT + file LICENSE
URL: https://github.com/R4SUB/r4subrisk
NeedsCompilation: no
Materials: README, NEWS
CRAN checks: r4subrisk results

Documentation:

Reference manual: r4subrisk.html , r4subrisk.pdf

Downloads:

Package source: r4subrisk_0.1.0.tar.gz
Windows binaries: r-devel: not available, r-release: r4subrisk_0.1.0.zip, r-oldrel: r4subrisk_0.1.0.zip
macOS binaries: r-release (arm64): r4subrisk_0.1.0.tgz, r-oldrel (arm64): r4subrisk_0.1.0.tgz, r-release (x86_64): r4subrisk_0.1.0.tgz, r-oldrel (x86_64): r4subrisk_0.1.0.tgz

Reverse dependencies:

Reverse suggests: r4subprofile

Linking:

Please use the canonical form https://CRAN.R-project.org/package=r4subrisk to link to this page.

These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.
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