SEND Dataset STUDYID Consistency
FDA’s June 2026 guide expects one consistent STUDYID across all records and all SEND datasets belonging to a study.
FDA’s June 2026 technical guide says all records in all SEND datasets for a study should carry the same STUDYID.
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
Use the same STUDYID throughout every SEND dataset for the study.
Purpose
Avoid dataset-level study-identifier drift that can break package-level consistency and reviewer automation.
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.