r4subrisk

r4subrisk is the risk quantification engine in the R4SUB ecosystem. It uses an FMEA-inspired framework (Probability × Impact × Detectability) to quantify submission risk, build risk registers, track mitigations, and emit standardized R4SUB evidence rows.

What are the key risks to submission readiness, how severe are they, and are they being addressed?

Installation

install.packages("r4subrisk")

Development version:

pak::pak(c("R4SUB/r4subcore", "R4SUB/r4subrisk"))

FMEA Risk Model

Each risk is scored on three dimensions (1–5 scale):

Probability: likelihood the issue persists to submission
Impact: regulatory consequence if unresolved
Detectability: difficulty of catching the issue (1 = easy, 5 = hard)

RPN (Risk Priority Number) = Probability × Impact × Detectability (range 1–125)

RPN	Level	Action
80–125	`critical`	Immediate action required
40–79	`high`	Must resolve before submission
15–39	`medium`	Plan mitigation
1–14	`low`	Monitor

Quick Start

library(r4subcore)
library(r4subrisk)

# Build a risk register manually
risks <- data.frame(
  risk_id       = c("R001", "R002"),
  description   = c("Missing SDTM variables", "Unmapped ADaM derivations"),
  category      = c("data_quality", "traceability"),
  probability   = c(4, 3),
  impact        = c(5, 4),
  detectability = c(2, 3)
)

rr     <- create_risk_register(risks)
scores <- compute_risk_scores(rr)

# Or derive risks from an evidence table
risk_items <- evidence_to_risks(evidence)
rr <- create_risk_register(risk_items)

# Emit r4subcore-compatible evidence rows
ctx <- r4sub_run_context(study_id = "ABC123", environment = "DEV")
ev  <- risk_register_to_evidence(rr, ctx = ctx)

Key Functions

Function	Purpose
`risk_config_default()`	FMEA scales, RPN bands, severity mappings
`classify_rpn()`	Classify an RPN value into a risk level
`create_risk_register()`	Build a risk register with RPN + levels
`evidence_to_risks()`	Derive risk items from r4subcore evidence
`compute_risk_scores()`	Aggregate risk metrics (mean/max RPN, distribution)
`risk_indicator_summary()`	Summary indicator table
`risk_register_to_evidence()`	Emit r4subcore-compatible evidence rows
`apply_mitigations()`	Update risks with mitigations, recompute RPN
`compare_risk_registers()`	Trend analysis between snapshots

Design Principles

FMEA-grounded: industry-standard risk methodology
Evidence-first: all risk items emit r4subcore evidence rows
Mitigation-aware: track and measure risk reduction over time
Transparent: every RPN is decomposable into P × I × D

Maintained by

R4SUB is part of the open-source work of TechWorksLab - clinical programming and regulatory submissions. Maintainer: Pawan Rama Mali.

License

MIT