What this package is | Run the bundled example | Add a study-specific rule
Package: openstudyval 0.1.1
Shekhar Eranna Chalwadi
openstudyval: Open Validator for FDA Study-Data Submissions
Validates clinical and nonclinical study-data packages against publicly described FDA technical-rejection criteria, SAS XPORT constraints from the Study Data Technical Conformance Guide, and an extensible catalog of SDTM, SEND, and ADaM structural conformance checks. Reads a study folder of CSV, RDS, or (when the suggested package haven is installed) SAS v5/v8 transport files, optionally checks define.xml, and writes a submission-style HTML and CSV validation report. This package is an independent open-source implementation. It is not affiliated with, endorsed by, or a copy of Pinnacle 21, Certara, or the FDA.
Authors:
openstudyval_0.1.1.tar.gz
openstudyval_0.1.1.zip(r-4.7-any)openstudyval_0.1.1.zip(r-4.6-any)openstudyval_0.1.1.zip(r-4.5-any)
openstudyval_0.1.1.tgz(r-4.6-any)openstudyval_0.1.1.tgz(r-4.5-any)
openstudyval_0.1.1.tar.gz(r-4.7-any)openstudyval_0.1.1.tar.gz(r-4.6-any)
openstudyval_0.1.1.tgz(r-4.6-emscripten)
manual.pdf |manual.html✨
DESCRIPTION |NEWS
card.svg |card.png
openstudyval/json (API)
| # Install 'openstudyval' in R: |
| install.packages('openstudyval', repos = c('https://shekharchalwadigrepo-hub.r-universe.dev', 'https://cloud.r-project.org')) |
Bug tracker:https://github.com/shekharchalwadigrepo-hub/openstudyval/issues
Last updated from:a445468d9f. Checks:9 OK. Indexed: yes.
| Target | Result | Time | Files | Syslog |
|---|---|---|---|---|
| linux-devel | OK | 122 | ||
| source / vignettes | OK | 211 | ||
| linux-release | OK | 123 | ||
| macos-release | OK | 96 | ||
| macos-oldrel | OK | 91 | ||
| windows-devel | OK | 76 | ||
| windows-release | OK | 70 | ||
| windows-oldrel | OK | 73 | ||
| wasm-release | OK | 85 |
Exports:add_custom_rulesexample_studyexplain_ruleread_study_datarules_catalogseverity_levelsvalidate_datasetsvalidate_submissionwrite_validation_report
Dependencies:
Readme and manuals
Help Manual
| Help page | Topics |
|---|---|
| Open validator for FDA study-data submissions | openstudyval-package openstudyval |
| Path to a bundled example study | example_study |
| Validation report object | as.data.frame.osv_report print.osv_report print.summary.osv_report summary.osv_report |
| Read a study-data folder | read_study_data |
| Rule catalog helpers | add_custom_rules explain_rule rules_catalog severity_levels |
| Validate datasets already in memory | validate_datasets |
| Validate a study-data folder | validate_submission |
| Write an HTML or CSV validation report | write_validation_report |