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.

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
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

Documentation:

Reference manual:	openstudyval.html , openstudyval.pdf
Vignettes:	Validating an FDA study-data package (source, R code)

Downloads:

Package source:	openstudyval_0.1.1.tar.gz
Windows binaries:	r-devel: not available, r-release: not available, r-oldrel: openstudyval_0.1.1.zip
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

Linking:

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