Articles tagged with “clinical-data-standards”

A 2026 comparison of Pinnacle 21, Nurocor and TCS ADD clinical metadata repositories, covering governance, CDISC coverage, study-build outputs, measured reuse, migration and a proof-of-concept script.

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.

A 2026 implementation guide to CDISC USDM 4.0, its API and Handbook 1, with a TA/TE/TV/TI/TS mapping, amendment controls, validation gates, and a bounded pilot worksheet.

A 2026 Define-XML 2.1 implementation guide covering field-level metadata controls, FDA version selection, value-level tests, link integrity, and reviewer navigation.

Learn the essential CDISC standards for clinical trial data. This guide explains SDTM and ADaM data models, their structure, regulatory requirements, and 2025-2026 updates including SDTM v3.0, Dataset-JSON, and ICH M11.