Analysis Programs in Module 5
FDA’s June 2026 conformance guide states that sponsors should provide source code used to create ADaM datasets, tables, and figures associated with primary and secondary efficacy analyses, and its folder table includes designated programs subfolders. This is FDA study-data submission guidance and does not imply that every analysis program from every internal workflow must be publicly or universally submitted.
Submit the applicable analysis source programs with the clinical analysis data in the designated Module 5 program location.
Key details
Important caveats
Scope Boundary
This is FDA study-data submission guidance and does not imply that every analysis program from every internal workflow must be publicly or universally submitted.
Further guidance
Content
Provide source code in the accepted submission format, keep it with the corresponding analysis structure, and identify the software version and operating system in the ADRG where the guide calls for that context.
Purpose
Submit the applicable analysis source programs with the clinical analysis data in the designated Module 5 program 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.