Split Study Dataset Files in eCTD
FDA’s June 2026 conformance guide states that datasets greater than 5 GB should be split into smaller datasets no larger than 5 GB for submission and placed in a separate split subdirectory, with the split explained in the relevant reviewer guide. The 5 GB threshold and directory handling are current FDA technical-conformance instructions and may change; do not generalize them to other regulators or future specifications without rechecking the current guide.
When a study dataset exceeds the current FDA processing threshold described by the guide, provide the smaller split datasets in the designated split subdirectory and explain how they were split in the relevant reviewer guide.
Key details
Important caveats
Scope Boundary
The 5 GB threshold and directory handling are current FDA technical-conformance instructions and may change; do not generalize them to other regulators or future specifications without rechecking the current guide.
Further guidance
Content
Retain the larger non-split dataset as directed by the current guidance and reduce character-variable lengths before splitting when that guidance applies.
Purpose
When a study dataset exceeds the current FDA processing threshold described by the guide, provide the smaller split datasets in the designated split subdirectory and explain how they were split in the relevant reviewer guide.
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.