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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.
Getting started
Browse package contents
Package details |
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| Author | Pawan Rama Mali [aut, cre, cph] |
| Maintainer | Pawan Rama Mali <prm@outlook.in> |
| License | MIT + file LICENSE |
| Version | 0.1.0 |
| URL | https://github.com/R4SUB/r4subrisk |
| Package repository | View on CRAN |
| Installation |
Install the latest version of this package by entering the following in R:
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