Laboratory Reference Ranges in FDA Clinical Study Data
FDA’s June 2026 guide says reference ranges should generally be provided for each laboratory result and unit, with appropriate ranges for relevant subpopulations such as pediatric subjects.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Provide the applicable reference range for each laboratory result/unit and use the appropriate subpopulation-specific range where relevant.
Key details
Core IssueFDA’s June 2026 guide says reference ranges should generally be provided for each laboratory result and unit, with appropriate ranges for relevant subpopulations such as pediatric subjects.
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
This page covers FDA clinical study-data reference-range representation; the inherited CSR normal-laboratory-ranges page remains the owner for narrative/report presentation.
Purpose
Provide the applicable reference range for each laboratory result/unit and use the appropriate subpopulation-specific range 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.
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.
ICH E3 section 12.4 calls for evaluation of laboratory data with attention to values over time, individual patient changes, and clinically significant abnormalities. The required detail depends on the study and reviewing authority; do not treat every laboratory measurement as equally important or duplicate raw listings in narrative form.
ICH E3 section 12.4.2 states that normal laboratory ranges should be given for each laboratory analysis alongside appropriate treatment-control comparisons. This page covers the explicit normal-range requirement in ICH E3 12.4.2; it does not replace the broader laboratory evaluation or patient-level listings.
ICH E3 section 12.4.1 points to a by-patient listing of abnormal laboratory values in section 14.3.4 and distinguishes that safety display from the broader listing of individual laboratory measurements. This page is about the dedicated abnormal-value listing under ICH E3 14.3.4; it is distinct from the full individual-measurement appendix under 16.2.8 and from analytical discussion in section 12.4.2.
FDA’s June 2026 conformance guide notes that there is no single standard or best practice for all adjudication data and directs sponsors to document where adjudication data reside and how adjudicated values can be distinguished from original values.
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.
