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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

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 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

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

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 x I x D

License

MIT

These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.
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