Package: r4subrisk 0.3.0

Pawan Rama Mali

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 (Ready for Submission) evidence table rows via 'r4subcore'. Supports risk mitigation tracking and trend analysis across submission milestones.

Authors:Pawan Rama Mali [aut, cre, cph]

r4subrisk_0.3.0.tar.gz
r4subrisk_0.3.0.zip(r-4.7-any)r4subrisk_0.3.0.zip(r-4.6-any)r4subrisk_0.3.0.zip(r-4.5-any)
r4subrisk_0.3.0.tgz(r-4.6-any)r4subrisk_0.3.0.tgz(r-4.5-any)
r4subrisk_0.3.0.tar.gz(r-4.7-any)r4subrisk_0.3.0.tar.gz(r-4.6-any)
r4subrisk_0.3.0.tgz(r-4.6-emscripten)
manual.pdf |manual.html✨
DESCRIPTION |NEWS
card.svg |card.png
r4subrisk/json (API)

# Install 'r4subrisk' in R:
install.packages('r4subrisk', repos = c('https://r4sub.r-universe.dev', 'https://cloud.r-project.org'))

Bug tracker:https://github.com/r4sub/r4subrisk/issues

Pkgdown/docs site:https://r4sub.github.io

On CRAN:

Conda:

5.32 score 1 packages 231 downloads 19 exports 18 dependencies

Last updated from:eac2e26001. Checks:9 OK. Indexed: yes.

TargetResultTimeFilesSyslog
linux-develOK129
source / vignettesOK185
linux-releaseOK127
macos-releaseOK94
macos-oldrelOK106
windows-develOK79
windows-releaseOK65
windows-oldrelOK88
wasm-releaseOK99

Exports:apply_mitigationsapply_risk_modelclassify_rpncompare_risk_registerscompute_risk_scorescreate_risk_registerevidence_to_risksplot_risk_heatmaprisk_config_defaultrisk_heatmap_datarisk_indicator_summaryrisk_modelrisk_model_fmearisk_model_ich_q9risk_model_overallrisk_model_probability_impactrisk_monte_carlorisk_reduction_summaryrisk_register_to_evidence

Dependencies:clidplyrgenericsgluejsonlitelifecyclemagrittrpillarpkgconfigr4subcoreR6rlangtibbletidyselectutf8vctrswithrxml2

Case study: FMEA risk on a pilot submission
The register | The risk picture | Working the highest risks | Before and after | Feeding the readiness score
Rendered fromcase-study-fmea-pilot.Rmdusingknitr::rmarkdown

Last update: 2026-08-04
Started: 2026-08-04

Risk Management with r4subrisk
Default configuration | Creating a risk register | Computing risk scores | Applying mitigations | Comparing registers | Integration with r4subcore evidence | Reduction summary | Risk heatmap | Alternative risk models
Rendered fromrisk-management.Rmdusingknitr::rmarkdown

Last update: 2026-08-04
Started: 2026-03-16

Readme and manuals

Help Manual

Help pageTopics
Update Risk Mitigation Statusapply_mitigations
Score Risks with a Modelapply_risk_model
Classify RPN Value into Risk Levelclassify_rpn
Compare Risk Registers (Trend Analysis)compare_risk_registers
Compute Risk Scores from a Risk Registercompute_risk_scores
Create a Risk Registercreate_risk_register
Derive Risk Items from Evidenceevidence_to_risks
Plot an FMEA Risk Heatmapplot_risk_heatmap
Print a Risk Modelprint.risk_model
Print Monte Carlo Risk Resultprint.risk_monte_carlo
Print a Risk Reduction Summaryprint.risk_reduction
Print Risk Registerprint.risk_register
Print Risk Scoresprint.risk_scores
Default Risk Configurationrisk_config_default
Build Risk Heatmap Datarisk_heatmap_data
Compute Risk Indicator Summaryrisk_indicator_summary
Define a Risk Scoring Modelrisk_model
Overall Normalized Risk from a Scored Setrisk_model_overall
Pre-Built Risk Modelsrisk_models risk_model_fmea risk_model_ich_q9 risk_model_probability_impact
Monte Carlo Uncertainty on Risk Priority Numbersrisk_monte_carlo
Summarize Risk Reduction Between Two Registersrisk_reduction_summary
Convert Risk Register to R4SUB Evidencerisk_register_to_evidence