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.
| Version: | 0.1.1 |
| Depends: | R (≥ 4.1.0) |
| Imports: | stats, tools, utils |
| Suggests: | haven, xml2, knitr, rmarkdown, testthat (≥ 3.0.0) |
| Published: | 2026-10-21 |
| DOI: | 10.32614/CRAN.package.openstudyval (may not be active yet) |
| Author: | Shekhar Eranna Chalwadi [aut, cre] |
| Maintainer: | Shekhar Eranna Chalwadi <skrchalwadicg at gmail.com> |
| BugReports: | https://github.com/shekharchalwadigrepo-hub/openstudyval/issues |
| License: | MIT + file LICENSE |
| URL: | https://github.com/shekharchalwadigrepo-hub/openstudyval |
| NeedsCompilation: | no |
| Language: | en-US |
| Citation: | openstudyval citation info |
| Materials: | NEWS |
| CRAN checks: | openstudyval results |
| Reference manual: | openstudyval.html , openstudyval.pdf |
| Vignettes: |
Validating an FDA study-data package (source, R code) |
| Package source: | openstudyval_0.1.1.tar.gz |
| Windows binaries: | r-devel: not available, r-release: not available, r-oldrel: not available |
| macOS binaries: | r-release (arm64): openstudyval_0.1.1.tgz, r-oldrel (arm64): openstudyval_0.1.1.tgz, r-release (x86_64): openstudyval_0.1.1.tgz, r-oldrel (x86_64): openstudyval_0.1.1.tgz |
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