Study Data Reviewer’s Guide for Nonclinical Data
FDA’s June 2026 Study Data Technical Conformance Guide recommends a nonclinical Study Data Reviewer’s Guide (nSDRG) as part of a standards-compliant nonclinical study-data submission and places it with study data in Module 4. This is FDA study-data submission guidance, not a universal requirement for every nonclinical report or every regulator.
Provide the nSDRG with nonclinical study data in Module 4 to explain special considerations, directions, or conformance issues that help reviewers use the submitted data and connect it with the study report.
Key details
Important caveats
Scope Boundary
This is FDA study-data submission guidance, not a universal requirement for every nonclinical report or every regulator.
Further guidance
Content
Use the current FDA naming and applicable eCTD tagging or document-type conventions; the guide identifies the submitted PDF as nsdrg.pdf.
Purpose
Provide the nSDRG with nonclinical study data in Module 4 to explain special considerations, directions, or conformance issues that help reviewers use the submitted data and connect it with the study report.
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.