Package: r4subdata 0.1.2
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.
Authors:
r4subdata_0.1.2.tar.gz
r4subdata_0.1.2.zip(r-4.7)r4subdata_0.1.2.zip(r-4.6)r4subdata_0.1.2.zip(r-4.5)
r4subdata_0.1.2.tgz(r-4.6-any)r4subdata_0.1.2.tgz(r-4.5-any)
r4subdata_0.1.2.tar.gz(r-4.7-any)r4subdata_0.1.2.tar.gz(r-4.6-any)
r4subdata_0.1.2.tgz(r-4.6-emscripten)
manual.pdf |manual.html✨
DESCRIPTION |NEWS
card.svg |card.png
r4subdata/json (API)
| # Install 'r4subdata' in R: |
| install.packages('r4subdata', repos = c('https://r4sub.r-universe.dev', 'https://cloud.r-project.org')) |
Bug tracker:https://github.com/r4sub/r4subdata/issues
Pkgdown/docs site:https://r4sub.github.io
- adam_metadata - ADaM Variable-Level Metadata
- evidence_pharma - Pharma Study Evidence Table
- oncology_evidence - Oncology Trial Evidence Table
- oncology_metadata - Oncology Trial Variable-Level Metadata
- regulatory_indicators - Regulatory Indicator Definitions
- risk_register_pharma - Pharma Risk Register
- sdtm_metadata - SDTM Variable-Level Metadata
- trace_mapping - ADaM-to-SDTM Traceability Mapping
Last updated from:1164e77192. Checks:9 OK. Indexed: yes.
| Target | Result | Time | Files | Syslog |
|---|---|---|---|---|
| linux-devel-x86_64 | OK | 105 | ||
| source / vignettes | OK | 150 | ||
| linux-release-x86_64 | OK | 115 | ||
| macos-release-arm64 | OK | 81 | ||
| macos-oldrel-arm64 | OK | 81 | ||
| windows-devel | OK | 92 | ||
| windows-release | OK | 83 | ||
| windows-oldrel | OK | 69 | ||
| wasm-release | OK | 98 |
Exports:dataset_dictionarylist_datasets
Dependencies:cligluelifecyclemagrittrpillarpkgconfigrlangtibbleutf8vctrs
Readme and manuals
Help Manual
| Help page | Topics |
|---|---|
| ADaM Variable-Level Metadata | adam_metadata |
| Dataset Column Dictionary | dataset_dictionary |
| Pharma Study Evidence Table | evidence_pharma |
| List Available r4subdata Datasets | list_datasets |
| Oncology Trial Evidence Table | oncology_evidence |
| Oncology Trial Variable-Level Metadata | oncology_metadata |
| Regulatory Indicator Definitions | regulatory_indicators |
| Pharma Risk Register | risk_register_pharma |
| SDTM Variable-Level Metadata | sdtm_metadata |
| ADaM-to-SDTM Traceability Mapping | trace_mapping |
