NEWS.md

In openstudyval: Open Validator for FDA Study-Data Submissions

openstudyval 0.1.1

• Switched inst/CITATION from citEntry() to bibentry().
• Added inst/WORDLIST for CDISC and FDA terms used in DESCRIPTION.

openstudyval 0.1.0

• Initial CRAN-candidate release.
• Submission validator for a study folder (CSV, RDS, and SAS XPORT when haven is installed).
• Engines for SDTM, SEND, and ADaM structural checks, XPORT constraints, and FDA eCTD technical-rejection criteria 1734, 1735, 1736, and 1738.
• Optional define.xml cross-check when xml2 is installed.
• Extensible rule catalog (CSV) and HTML/CSV validation report.
• Independent implementation. Not affiliated with Pinnacle 21 or the FDA.

openstudyval documentation built on Oct. 21, 2026, 5:14 p.m.