SEND Datasets in Module 4
FDA’s June 2026 conformance guide treats SEND as the standardized tabulation format for applicable nonclinical study data and places nonclinical study-data reviewer material with the study data in eCTD Module 4. SEND applicability depends on study type, center, dates, and the current FDA Data Standards Catalog; this guide does not claim that every nonclinical study universally requires SEND.
For applicable FDA nonclinical study submissions, organize SEND study data in the nonclinical Module 4 study-data context and follow the current supported SEND version, eCTD, and study-data specifications.
Key details
Important caveats
Scope Boundary
SEND applicability depends on study type, center, dates, and the current FDA Data Standards Catalog; this guide does not claim that every nonclinical study universally requires SEND.
Further guidance
Content
Keep SEND data, define.xml, reviewer-guide information, study identifiers, and any applicable technical-rejection metadata consistent with the current FDA standards catalog and eCTD version.
Purpose
For applicable FDA nonclinical study submissions, organize SEND study data in the nonclinical Module 4 study-data context and follow the current supported SEND version, eCTD, and study-data specifications.
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.