eCTD Dataset Folder Structure
FDA’s June 2026 conformance guide specifies an electronic file-directory structure for study datasets that is distinct from the eCTD heading hierarchy and provides designated folders for clinical data in Module 5. This is FDA electronic-submission organization guidance; the directory structure should not be presented as the universal physical folder scheme for all regulators or non-eCTD work.
Organize study datasets and supporting files in the FDA-specified dataset directory structure so automated review systems can detect and prepare them consistently.
Key details
Important caveats
Scope Boundary
This is FDA electronic-submission organization guidance; the directory structure should not be presented as the universal physical folder scheme for all regulators or non-eCTD work.
Further guidance
Content
Use the module, datasets, study, analysis/tabulations, dataset, program, profile, and other applicable subfolders defined for the submission rather than placing files at parent levels that are not intended to contain files.
Purpose
Organize study datasets and supporting files in the FDA-specified dataset directory structure so automated review systems can detect and prepare them consistently.
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.