Study Data File Tags in eCTD
FDA’s June 2026 conformance guide uses eCTD v3.2.2 file tags and eCTD v4.0 document type keywords to identify study-data and study-report documents for processing and review. These requirements are current FDA technical-conformance guidance for electronic study-data submissions and should be rechecked when FDA guidance, supported standards, or eCTD specifications change.
Apply the current FDA eCTD file tag or document type keyword that corresponds to the submitted study-data or report document and the eCTD version in use.
Key details
Important caveats
Scope Boundary
These requirements are current FDA technical-conformance guidance for electronic study-data submissions and should be rechecked when FDA guidance, supported standards, or eCTD specifications change.
Further guidance
Content
Do not treat a v3.2.2 file tag and a v4.0 document type keyword as interchangeable labels; use the metadata convention required by the submission version.
Purpose
Apply the current FDA eCTD file tag or document type keyword that corresponds to the submitted study-data or report document and the eCTD version in use.
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.