Sex of Participants (SEXPOP) in FDA SEND Trial Summary Data
In the June 2026 FDA Study Data Technical Conformance Guide, SEXPOP is the Trial Summary parameter code for Sex of Participants; FDA lists it as desired for nonclinical Trial Summary data. This is FDA submission guidance, not a universal SEND rule detached from the current FDA-supported standards and conformance guide.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
For FDA nonclinical SEND Trial Summary data, use SEXPOP for Sex of Participants; FDA marks this parameter as desired.
Key details
Core IssueIn the June 2026 FDA Study Data Technical Conformance Guide, SEXPOP is the Trial Summary parameter code for Sex of Participants; FDA lists it as desired for nonclinical Trial Summary data.
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Important caveats
Scope Boundary
This page is narrowly scoped to the June 2026 FDA technical-conformance table for nonclinical Trial Summary parameters; recheck current FDA guidance and supported standards before relying on version-sensitive submission requirements.
Further guidance
Content
For FDA nonclinical SEND Trial Summary data, use SEXPOP for Sex of Participants; FDA marks this parameter as desired.
Purpose
Represent Sex of Participants in the nonclinical TS dataset with parameter code SEXPOP, following the current FDA table, the applicable supported SEND implementation guide, and controlled terminology where relevant.
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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