SEND Submission Folder Contents and File Naming
FDA’s June 2026 guide specifies core SEND package organization, including the SEND tabulations folder, supporting nSDRG/define.xml files, and concise domain-based dataset filenames.
FDA’s June 2026 guide describes the expected SEND package location and supporting files, and says dataset filenames should use the domain abbreviation plus the file extension without extra qualifiers.
Key details
Important caveats
Scope Boundary
This is current FDA technical-conformance guidance for electronic study-data submissions; recheck the current FDA guide, supported standards, Data Standards Catalog, and eCTD specifications before relying on version-sensitive requirements.
Further guidance
Content
Place the SEND datasets and required supporting files in the expected study tabulations location, avoid unrequested subfolders, and use domain-abbreviation dataset filenames as described by the guide.
Purpose
Keep a SEND package structurally predictable for automated validation and reviewer navigation.
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.