FDA’s June 2026 conformance guide says the Subject Elements (SE) domain should be included to help associate subject findings, events, and interventions with the study element in which they occurred.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Include the SE domain when applying the current FDA conformance guidance so subject data can be associated with the study element in which it occurred.
Key details
Core IssueFDA’s June 2026 conformance guide says the Subject Elements (SE) domain should be included to help associate subject findings, events, and interventions with the study element in which they occurred.
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
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.
Purpose
Include the SE domain when applying the current FDA conformance guidance so subject data can be associated with the study element in which it occurred.
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.
FDA’s June 2026 guide states an Agency preference for submitting scheduled and unscheduled clinical subject visits together in one dataset structured as the current SDTM SV domain.
FDA’s June 2026 guide says the AE domain should include all adverse events unless an indication-specific technical specification says otherwise and asks for the criterion supporting a serious-event flag.
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.
FDA’s June 2026 conformance guide says screen failures, when provided, should be represented as a DM record with specified planned/actual arm fields left blank.
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.
FDA’s June 2026 guide explicitly calls for the DV domain in submissions containing protocol-deviation data and identifies review-oriented variables beyond CDISC-required fields.
