Study Report Endpoint Coverage in FDA SEND Package
FDA’s June 2026 guide calls for package-level verification that modeled study-report endpoints are present in SEND and that endpoints not included in SEND are disclosed in the nSDRG.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
FDA’s June 2026 guide says endpoints included in the study report should be represented in SEND when the standard models them; endpoints not represented in SEND should be identified in the nSDRG.
Key details
Core IssueFDA’s June 2026 guide calls for package-level verification that modeled study-report endpoints are present in SEND and that endpoints not included in SEND are disclosed in the nSDRG.
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
Verify that study-report endpoints supported by SEND are present in the datasets, and list report endpoints not represented in SEND in the nSDRG.
Purpose
Make the relationship between the study report and the structured SEND package explicit for reviewers.
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.
In the June 2026 FDA Study Data Technical Conformance Guide, STRPSTAT is the Trial Summary parameter code for Study Report Status; 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.
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 provides explicit SEND PC-domain handling for pharmacokinetic concentration results below the lower limit of quantitation (LLOQ).
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.
In the June 2026 FDA Study Data Technical Conformance Guide, STCAT is the Trial Summary parameter code for Study Category; 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.
In the June 2026 FDA Study Data Technical Conformance Guide, SDESIGN is the Trial Summary parameter code for Study Design; 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.
In the June 2026 FDA Study Data Technical Conformance Guide, STDIR is the Trial Summary parameter code for Study Director; 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.
