Categorical Laboratory Results in FDA SEND Study Data
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.
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Quick answer
For categorical noncontinuous laboratory results in SEND, FDA’s June 2026 guide says to put the result in LBSTRESC and leave LBSTRESN null even when category labels are numeric; the full scale should be explained in the nSDRG.
Key details
Core IssueFDA’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.
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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
Represent categorical noncontinuous lab outcomes in LBSTRESC, keep LBSTRESN null for those categorical results, and document the full scale in the nSDRG.
Purpose
Do not treat numeric-looking category labels as continuous numeric laboratory values.
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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