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r4subdata

R-CMD-check CRAN status CRAN downloads r-universe

r4subdata provides realistic example datasets for the R4SUB clinical submission readiness ecosystem — designed for demos, vignettes, and package testing, like nycflights13 or palmerpenguins.

Installation

install.packages("r4subdata")

Development version:

pak::pak("R4SUB/r4subdata")

Datasets

Dataset Rows Description
evidence_pharma 250 Full evidence table for study CDISCPILOT01 across 4 domains
adam_metadata 36 ADaM variable metadata for ADSL, ADAE, ADLB
sdtm_metadata 43 SDTM variable metadata for DM, AE, LB
trace_mapping 25 ADaM-to-SDTM traceability mapping with confidence scores
risk_register_pharma 18 FMEA risk register with P/I/D scores and mitigations
regulatory_indicators 30 Indicator definitions across quality, trace, risk, usability
oncology_metadata 32 ADaM variable metadata for ONCO-2025-001 (ADSL, ADRS, ADTTE)
oncology_evidence 29 Evidence table for ONCO-2025-001 across all 4 pillars
library(r4subdata)
list_datasets()

Quick Start

library(r4subdata)

# Explore available datasets
list_datasets()

# Load and inspect
data(evidence_pharma)
table(evidence_pharma$indicator_domain)

# Column dictionary
dataset_dictionary("evidence_pharma")

Usage with R4SUB Packages

library(r4subcore)
library(r4subscore)
library(r4subdata)

# Score the pharma evidence
scores  <- compute_indicator_scores(evidence_pharma)
pillars <- compute_pillar_scores(evidence_pharma)
sci     <- compute_sci(pillars)

# Traceability
library(r4subtrace)
model <- build_trace_model(adam_metadata, sdtm_metadata, trace_mapping)

# Risk analysis
library(r4subrisk)
rr <- create_risk_register(risk_register_pharma)

# Oncology study
scores_onco <- compute_indicator_scores(oncology_evidence)

License

MIT

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Example datasets for the R4SUB clinical submission readiness ecosystem

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