LB Dataset Splitting by LBCAT and LBSCAT
FDA’s June 2026 guide gives a laboratory-domain-specific splitting method for very large LB datasets: split first by LBCAT and, if still too large, by LBSCAT.
For a large LB dataset that must be split, use LBCAT for the initial split and LBSCAT for further splitting if needed, while retaining the non-split LB file and documenting the split location.
Key details
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 the LB-specific category/subcategory splitting method; the inherited general file-size guide remains the broader owner for the overall 5 GB dataset-splitting requirement.
Purpose
For a large LB dataset that must be split, use LBCAT for the initial split and LBSCAT for further splitting if needed, while retaining the non-split LB file and documenting the split location.
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.
- Study Data Technical Conformance Guide - Technical Specifications Document (opens in a new tab)U.S. Food and Drug Administration · Current FDA technical specifications for standardized clinical and nonclinical study-data submissions, including reviewer guides, datasets and eCTD organization.