FDA’s June 2026 conformance guide describes when a simplified ts.xpt trial-summary file can provide limited machine-readable study information for specified clinical or nonclinical submissions that do not require the full standardized dataset package. These requirements are current FDA technical-conformance guidance for electronic study-data submissions and should be rechecked when FDA guidance, supported standards, or eCTD specifications change.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Use a simplified ts.xpt only in the current FDA situations where the conformance guide permits or expects it, and follow the specified trial-summary structure.
Key details
Core IssueFDA’s June 2026 conformance guide describes when a simplified ts.xpt trial-summary file can provide limited machine-readable study information for specified clinical or nonclinical submissions that do not require the full standardized dataset package.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
These requirements are current FDA technical-conformance guidance for electronic study-data submissions and should be rechecked when FDA guidance, supported standards, or eCTD specifications change.
Further guidance
Content
A simplified ts.xpt is not a substitute for full SDTM/ADaM/SEND data when those standards are required; its applicability depends on study type, dates, center, application context, and current FDA criteria.
Purpose
Use a simplified ts.xpt only in the current FDA situations where the conformance guide permits or expects it, and follow the specified trial-summary structure.
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 describes the DD (Death Details) domain for supplemental information collected when a death occurs and expects consistency with relevant AE-domain death variables.
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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.
FDA’s June 2026 guide gives a direct placement rule for viral-load results in standardized clinical study data: place them in the MB (Microbiology) domain.
