DS Domain for Multiple Disposition Events in FDA Study Data
FDA’s June 2026 guide gives DS-domain handling for multiple disposition events, including use of EPOCH or DSSCAT and a specific final-record convention for death.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
When a subject has multiple disposition events, FDA’s June 2026 technical guide says to use EPOCH or DSSCAT to distinguish the events in the DS domain; for a subject who dies, death should be the last disposition record with EPOCH populated.
Key details
Core IssueFDA’s June 2026 guide gives DS-domain handling for multiple disposition events, including use of EPOCH or DSSCAT and a specific final-record convention for death.
Registerscholarly, professional, or research/report writing
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
For multiple disposition events, distinguish records using EPOCH or DSSCAT as the guide describes. For a subject who dies, the death disposition is the last record and EPOCH should be populated.
Purpose
Make repeated subject-disposition records interpretable to reviewers without inventing a custom event-order convention.
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.
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