FDA’s June 2026 Study Data Technical Conformance Guide recommends a clinical Study Data Reviewer’s Guide (cSDRG) as part of a standards-compliant clinical study-data submission and places it with study data in Module 5. This is FDA study-data submission guidance, not a universal requirement for every clinical report or every regulator.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Provide the cSDRG with the clinical study data in Module 5 to explain special considerations, directions, or conformance issues that help reviewers use the submitted data.
Key details
Core IssueFDA’s June 2026 Study Data Technical Conformance Guide recommends a clinical Study Data Reviewer’s Guide (cSDRG) as part of a standards-compliant clinical study-data submission and places it with study data in Module 5.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This is FDA study-data submission guidance, not a universal requirement for every clinical report or every regulator.
Further guidance
Content
Use the current FDA naming and applicable eCTD tagging or document-type conventions; the guide identifies the clinical file as csdrg.pdf.
Purpose
Provide the cSDRG with the clinical study data in Module 5 to explain special considerations, directions, or conformance issues that help reviewers use the submitted 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.
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.
FDA’s June 2026 Study Data Technical Conformance Guide recommends an Analysis Data Reviewer’s Guide (ADRG) as a single orientation point for analysis datasets and states that the clinical-study ADRG belongs with the analysis data in Module 5. This is FDA submission guidance for analysis data and should not be generalized as a universal document requirement outside the applicable regulatory context.
ICH E3 distinguishes specified patient listings in Appendix 16.2 from all individual-patient archival listings requested only in the United States under Appendix 16.4. The Appendix 16.4 archival-listing statement is explicitly U.S.-specific in ICH E3 and should not be generalized to every ICH region.
