# ------------------------------------------------ # CITATION.cff file created with {cffr} R package # See also: https://docs.ropensci.org/cffr/ # ------------------------------------------------ cff-version: 1.2.0 message: 'To cite package "openstudyval" in publications use:' type: software license: MIT title: 'openstudyval: Open Validator for FDA Study-Data Submissions' version: 0.1.1 identifiers: - type: doi value: 10.32614/CRAN.package.openstudyval abstract: 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: - family-names: Chalwadi given-names: Shekhar Eranna email: skrchalwadicg@gmail.com preferred-citation: type: manual title: 'openstudyval: Open Validator for FDA Study-Data Submissions' authors: - family-names: Chalwadi given-names: Shekhar Eranna email: skrchalwadicg@gmail.com year: '2026' notes: R package version 0.1.1 url: https://github.com/shekharchalwadigrepo-hub/openstudyval repository: https://shekharchalwadigrepo-hub.r-universe.dev repository-code: https://github.com/shekharchalwadigrepo-hub/openstudyval commit: a445468d9f9e64315772a12324ceba6df81f5174 url: https://github.com/shekharchalwadigrepo-hub/openstudyval date-released: '2026-10-12' contact: - family-names: Chalwadi given-names: Shekhar Eranna email: skrchalwadicg@gmail.com