FDA’s June 2026 guide describes the DD (Death Details) domain for supplemental information collected when a death occurs and expects consistency with relevant AE-domain death variables.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Use DD for supplemental death details such as official cause of death, and keep the related AE outcome/death/end-date variables consistent with those details.
Key details
Core IssueFDA’s June 2026 guide describes the DD (Death Details) domain for supplemental information collected when a death occurs and expects consistency with relevant AE-domain death variables.
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
The guide identifies DD as the supplemental death-details domain and specifically connects it to AEOUT, AESDTH, and AEENDTC/AEENDY consistency.
Purpose
Use DD for supplemental death details such as official cause of death, and keep the related AE outcome/death/end-date variables consistent with those details.
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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