FDA’s June 2026 guide provides FDA-specific Trial Summary parameter guidance for nonclinical SEND submissions.
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Quick answer
FDA’s June 2026 guide provides FDA-specific Trial Summary parameter expectations for SEND, including parameter/value conventions that should align with the applicable standards catalog and technical specifications.
Key details
Core IssueFDA’s June 2026 guide provides FDA-specific Trial Summary parameter guidance for nonclinical SEND submissions.
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
Populate SEND Trial Summary parameters using the applicable FDA-specific parameter conventions and exact catalog/specification terms where the guide calls for them.
Purpose
Keep machine-readable study-level metadata aligned with the FDA-supported standard and current technical specifications.
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 PC-domain timing/grouping details needed for SEND time-series use, including nominal timing relative to dose and information that identifies measurements within the exposure context.
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.
In the June 2026 FDA Study Data Technical Conformance Guide, ASOCSTDY is the Trial Summary parameter code for Associated Study; FDA lists it as conditional for nonclinical Trial Summary data. FDA notes: include it if applicable. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
FDA’s June 2026 guide separates categorical noncontinuous laboratory results from numeric continuous results by using LBSTRESC, leaving LBSTRESN null, and documenting the categorical scale in the nSDRG.
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.
