--- title: "Example Datasets in r4subdata" output: rmarkdown::html_vignette vignette: > %\VignetteIndexEntry{Example Datasets in r4subdata} %\VignetteEngine{knitr::rmarkdown} %\VignetteEncoding{UTF-8} --- ```{r setup, include = FALSE} knitr::opts_chunk$set(collapse = TRUE, comment = "#>") ``` The `r4subdata` package provides synthetic example datasets for the R4SUB (R for Regulatory Submission) ecosystem. They are suitable for demos, vignettes, and package testing. ```{r load} library(r4subdata) ``` ## Available datasets Use `list_datasets()` to see all datasets with descriptions: ```{r list} list_datasets() ``` ## Pharma study evidence table `evidence_pharma` is a 250-row evidence table for study CDISCPILOT01, covering all four R4SUB pillars. ```{r evidence-pharma} data(evidence_pharma) dim(evidence_pharma) table(evidence_pharma$indicator_domain) table(evidence_pharma$result) ``` ## ADaM metadata `adam_metadata` contains variable-level metadata for three ADaM datasets: ADSL, ADAE, and ADLB. ```{r adam} data(adam_metadata) table(adam_metadata$dataset) head(adam_metadata[, c("dataset", "variable", "label", "type")]) ``` ## SDTM metadata `sdtm_metadata` mirrors the same structure for SDTM domains DM, AE, and LB. ```{r sdtm} data(sdtm_metadata) table(sdtm_metadata$dataset) ``` ## Traceability mapping `trace_mapping` links ADaM variables to their SDTM source variables. ```{r trace} data(trace_mapping) head(trace_mapping) ``` ## Risk register `risk_register_pharma` is an FMEA-based risk register with 18 risks structured according to ICH Q9 principles. ```{r risk} data(risk_register_pharma) table(risk_register_pharma$category) table(risk_register_pharma$status) ``` ## Regulatory indicator definitions `regulatory_indicators` is a reference table of 30 indicator definitions across all four R4SUB domains. ```{r indicators} data(regulatory_indicators) table(regulatory_indicators$domain) ``` ## Oncology trial datasets Two additional datasets represent a synthetic oncology submission (study ONCO-2025-001) with ADSL, ADRS, and ADTTE datasets. ```{r oncology-meta} data(oncology_metadata) table(oncology_metadata$dataset) table(oncology_metadata$origin) ``` ```{r oncology-ev} data(oncology_evidence) table(oncology_evidence$indicator_domain) table(oncology_evidence$result) ``` The oncology metadata includes `origin`, `derivation`, and `codelist` columns needed by `r4subusability::assess_define_completeness()` and `r4subusability::assess_annotation_coverage()`.