Changes in version 0.1.1 (2026-10-21) - Switched inst/CITATION from citEntry() to bibentry(). - Added inst/WORDLIST for CDISC and FDA terms used in DESCRIPTION. Changes in version 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.