Define.xml for Analysis Datasets
FDA’s June 2026 conformance guide calls for a separate data-definition file for ADaM analysis datasets and identifies define.xml as the XML submission form for that metadata. This page is scoped to FDA standardized study-data submissions; define.xml implementation details remain governed by the current supported standards and FDA catalog.
Provide the analysis-data define.xml as the metadata companion to the submitted ADaM datasets.
Key details
Important caveats
Scope Boundary
This page is scoped to FDA standardized study-data submissions; define.xml implementation details remain governed by the current supported standards and FDA catalog.
Further guidance
Content
Document dataset and variable metadata clearly, including controlled terminology and derivation-relevant details, and use the applicable analysis-data-definition tag or document keyword for the eCTD version.
Purpose
Provide the analysis-data define.xml as the metadata companion to the submitted ADaM datasets.
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.