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r4subscore is the scoring and calibration engine of the R4SUB ecosystem. It converts standardized evidence (from r4subcore and companion packages) into a Submission Confidence Index (SCI) — a single 0–100 score with decision bands, explainability tables, and sensitivity analysis.

Are we ready for regulatory submission — and how confident are we?

Installation

install.packages("r4subscore")

Development version:

pak::pak(c("R4SUB/r4subcore", "R4SUB/r4subscore"))

Quick Start

library(r4subcore)
library(r4subscore)

pillar_scores <- compute_pillar_scores(ev)
sci           <- compute_sci(pillar_scores)

sci$SCI   # 0–100
sci$band  # "ready", "minor_gaps", "conditional", or "high_risk"

SCI Decision Bands

SCI Band Interpretation
85–100 ready Ready for Submission
70–84 minor_gaps Minor Gaps to Address
50–69 conditional Conditional — Address Key Issues
0–49 high_risk High Risk

Scoring Logic

  1. Each evidence row gets a weighted score: result_score × (1 − severity_weight)
  2. Indicator scores = mean weighted score per indicator
  3. Pillar scores = mean indicator score per domain (quality, trace, risk, usability)
  4. SCI = weighted sum of pillar scores × 100

Key Functions

Function Purpose
sci_config_default() Pillar weights and decision bands configuration
classify_band() Classify an SCI value into a decision band
compute_indicator_scores() Severity-weighted indicator-level scores
compute_pillar_scores() Aggregate indicators into pillar scores
compute_sci() Compute SCI (0–100) and band classification
sci_sensitivity_analysis() SCI under alternative weight scenarios
sci_explain() Top loss contributors and pillar breakdown

Integration with r4subprofile

library(r4subprofile)
library(r4subscore)

prof <- submission_profile("FDA", "NDA")
cfg  <- profile_sci_config(prof)

pillar_scores <- compute_pillar_scores(ev, config = cfg)
sci           <- compute_sci(pillar_scores, config = cfg)

License

MIT