r4subrisk-package: r4subrisk: Risk Quantification Engine for Clinical Submission...

r4subrisk-packageR Documentation

r4subrisk: Risk Quantification Engine for Clinical Submission Readiness

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.

Author(s)

Maintainer: Pawan Rama Mali prm@outlook.in [copyright holder]

See Also

Useful links:


r4subrisk documentation built on March 4, 2026, 1:07 a.m.