r4subdata
Example Datasets for Clinical Submission Readiness
Provides realistic synthetic example datasets for the R4SUB (R for Regulatory Submission) ecosystem. Includes a pharma study evidence table, ADaM (Analysis Data Model) and SDTM (Study Data Tabulation Model) metadata following CDISC (Clinical Data Interchange Standards Consortium) conventions (< https://www.cdisc.org>), traceability mappings, a risk register based on ICH (International Council for Harmonisation) Q9 quality risk management principles (< https://www.ich.org/page/quality-guidelines>), and regulatory indicator definitions. Designed for demos, vignettes, and package testing.
r4subdata
r4subdata provides realistic example datasets for the R4SUB clinical submission readiness ecosystem.
Designed for demos, vignettes, and package testing -- like nycflights13 or palmerpenguins.
Installation
CRAN
install.packages("r4subdata")
Development install
# install.packages("pak")
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 |
Quick Start
library(r4subdata)
# Browse datasets
list_datasets()
# Load and explore
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)
# Trace with metadata
library(r4subtrace)
model <- build_trace_model(adam_metadata, sdtm_metadata, trace_mapping)
# Risk analysis
library(r4subrisk)
rr <- create_risk_register(risk_register_pharma)
License
MIT