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 Repository: https://shekharchalwadigrepo-hub.r-universe.dev Date/Publication: 2026-10-12 10:00:22 UTC RemoteUrl: https://github.com/shekharchalwadigrepo-hub/openstudyval RemoteRef: HEAD RemoteSha: a445468d9f9e64315772a12324ceba6df81f5174 Packaged: 2026-10-22 10:44:38 UTC; root Author: Shekhar Eranna Chalwadi [aut, cre] Maintainer: Shekhar Eranna Chalwadi