Define.xml for Tabulation Datasets
FDA’s June 2026 conformance guide describes data-definition files for standardized tabulation datasets and uses define.xml as the XML metadata companion for supported study-data standards. This page is scoped to FDA standardized study-data submissions and does not treat one define.xml implementation as universal across regulators or unsupported standard versions.
Provide the applicable tabulation-data define.xml so reviewers can interpret dataset and variable metadata for submitted standardized tabulation data.
Key details
Important caveats
Scope Boundary
This page is scoped to FDA standardized study-data submissions and does not treat one define.xml implementation as universal across regulators or unsupported standard versions.
Further guidance
Content
Keep clinical SDTM and nonclinical SEND metadata aligned with the supported standard versions and FDA Data Standards Catalog applicable to the submission.
Purpose
Provide the applicable tabulation-data define.xml so reviewers can interpret dataset and variable metadata for submitted standardized tabulation data.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- Study Data Technical Conformance Guide - Technical Specifications Document (opens in a new tab)U.S. Food and Drug Administration · Current FDA technical specifications for standardized clinical and nonclinical study-data submissions, including reviewer guides, datasets and eCTD organization.