README

r4subrisk

r4subrisk is the risk quantification engine in the R4SUB ecosystem.

It uses an FMEA-inspired framework (Probability x Impact x Detectability) to quantify submission risk, build risk registers, track mitigations, and emit standardized R4SUB evidence rows.

It answers the question:

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

Core Concepts

FMEA Risk Model

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

RPN Bands

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

80–125

critical

Immediate action required

40–79

high

Must resolve before submission

15–39

medium

Plan mitigation

1–14

low

Monitor

Installation

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

Quick Start

library(r4subcore)
library(r4subrisk)

# From a manual risk register
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)
rr

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

# Compute scores and emit evidence
scores <- compute_risk_scores(rr)
ctx <- r4sub_run_context(study_id = "ABC123", environment = "DEV")
ev <- risk_register_to_evidence(rr, ctx = ctx)

Core 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

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