Articles tagged with “define-xml”

CDISC Controlled Terminology Release Management Playbook

A 2026 guide to CDISC controlled terminology release management: semantic diffs, study version pinning, paired codelists, exception governance, and regression evidence, with a March 2026 worked example.

23 min read

10/13/2026

cdisc controlled terminology cdisc release management controlled terminology versioning study freeze sdtm adam define-xml clinical data standards terminology governance

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.

23 min read

9/26/2026

cdisc dataset-json 1.1 xpt equivalence dataset-json validation clinical data standards sas xport define-xml fda study data submission readiness data integrity

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.

22 min read

9/20/2026

fda study data standards fda data standards catalog sdtm send adam define-xml technical rejection criteria ectd clinical data management

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

25 min read

4/20/2026

send datasets fda nonclinical submissions cdisc standards sendig sdtm framework define-xml toxicology data nsdrg

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.

45 min read

11/14/2025

cdisc sdtm adam clinical trial data data standards regulatory submission cdash define-xml clinical data management