CDISC Dataset-JSON 1.1: XPT Equivalence Validation Guide
A 2026 protocol for validating CDISC Dataset-JSON 1.1 against XPT: canonical datasets, schema and metadata checks, round trips, nulls and precision, signed evidence, and FDA submission status.
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Articles tagged with “define-xml”
FDA Study Data Standards: Version and Rejection Matrix
A 2026 operational guide to FDA study data standards version selection, including catalog dates, SDTM, SEND, ADaM, Define-XML, and rejection preflight controls.
SEND Datasets Guide: FDA Nonclinical Submission Standards
Learn about CDISC SEND datasets for FDA nonclinical submissions. This guide explains SDTM framework alignment, SENDIG rules, and regulatory compliance timelines
CDISC Standards: How They Work with SDTM & ADaM Examples
Learn about CDISC standards for clinical trial data. This guide explains SDTM, ADaM, CDASH, and Define-XML with concrete examples for regulatory submissions.