Patient Profiles in Module 5
FDA’s June 2026 study-data folder table provides a Module 5 profiles subfolder for individual subject narratives and profiles and gives a review-oriented PDF organization convention. This is an FDA electronic-submission placement convention; whether patient profiles are appropriate or required depends on the submission and should not be generalized to every CSR.
Place individual subject narratives or profiles in the designated Module 5 profiles location when they are part of the FDA study-data submission.
Key details
Important caveats
Scope Boundary
This is an FDA electronic-submission placement convention; whether patient profiles are appropriate or required depends on the submission and should not be generalized to every CSR.
Further guidance
Content
For the profiles folder, follow the current FDA convention for combining and bookmarking submitted profile material to facilitate subject-level review.
Purpose
Place individual subject narratives or profiles in the designated Module 5 profiles location when they are part of the FDA study-data submission.
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.