Multiple Studies in a Single SEND Report
FDA’s June 2026 guide treats each study represented in a multi-study report as needing its own SEND package rather than collapsing multiple studies into one dataset package.
When one study report contains multiple consecutive studies, FDA’s June 2026 guide says each study should be submitted with its own SEND package and the report should be associated with the applicable packages.
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
Create a separate SEND package for each study represented in the report and associate the report with the applicable study packages as current guidance describes.
Purpose
Preserve study-level package boundaries even when multiple studies are presented together in one report.
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.