Legacy Data Conversion Plan and Report
FDA’s June 2026 conformance guide describes a Legacy Data Conversion Plan for the planned conversion process and a Legacy Data Conversion Report for the conversion results, issues, and their disposition when legacy study data are converted to a supported standard. The guide contains scope exceptions and context-specific expectations, including nonclinical situations; do not present legacy conversion documentation as mandatory for every study-data submission.
Document the planned conversion approach and the actual conversion results or issues so reviewers can understand how legacy study data became the submitted standardized data.
Key details
Important caveats
Scope Boundary
The guide contains scope exceptions and context-specific expectations, including nonclinical situations; do not present legacy conversion documentation as mandatory for every study-data submission.
Further guidance
Content
Present the relevant legacy-conversion information in the appropriate Study Data Reviewer’s Guide and explain material conversion issues that could affect interpretation or traceability.
Purpose
Document the planned conversion approach and the actual conversion results or issues so reviewers can understand how legacy study data became the submitted standardized data.
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.