Package: openstudyval
Type: Package
Title: Open Validator for FDA Study-Data Submissions
Version: 0.1.1
Authors@R: person(given = "Shekhar Eranna", family = "Chalwadi",
                  email = "skrchalwadicg@gmail.com",
                  role = c("aut", "cre"))
Description: 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.
License: MIT + file LICENSE
URL: https://github.com/shekharchalwadigrepo-hub/openstudyval
BugReports: https://github.com/shekharchalwadigrepo-hub/openstudyval/issues
Encoding: UTF-8
Language: en-US
Depends: R (>= 4.1.0)
Imports: stats, tools, utils
Suggests: haven, xml2, knitr, rmarkdown, testthat (>= 3.0.0)
VignetteBuilder: knitr
Config/testthat/edition: 3
RoxygenNote: 7.3.2
NeedsCompilation: no
Packaged: 2026-10-12 10:04:38 UTC; skrch
Author: Shekhar Eranna Chalwadi [aut, cre]
Maintainer: Shekhar Eranna Chalwadi <skrchalwadicg@gmail.com>
Repository: CRAN
Date/Publication: 2026-10-21 16:30:02 UTC
Built: R 4.6.1; ; 2026-10-21 17:16:34 UTC; unix
