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.
ReviewedEvidence2 sourcesSectionWriting & Style
Quick answer
Provide the ADRG with the clinical analysis data in Module 5 so reviewers have a focused orientation to the analysis datasets, terminology, and conformance context.
Key details
Core IssueFDA’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.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This is FDA submission guidance for analysis data and should not be generalized as a universal document requirement outside the applicable regulatory context.
Further guidance
Content
Use the current FDA naming, file-tag or document-type, and placement conventions applicable to the eCTD version being submitted; the ADRG supplements rather than replaces required dataset metadata such as define.xml.
Purpose
Provide the ADRG with the clinical analysis data in Module 5 so reviewers have a focused orientation to the analysis datasets, terminology, and conformance context.
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 Module 5 hierarchy includes analysis-dataset headings, and the current Study Data Technical Conformance Guide provides the technical framework for standardized analysis data submitted for clinical studies. This page concerns FDA study-data submission organization; it is not a substitute for the current Data Standards Catalog or study-specific review-division advice.
FDA’s Module 5 hierarchy provides data-tabulation headings, including standardized clinical tabulation data, while the current Study Data Technical Conformance Guide addresses supported study-data submission standards and organization. This is FDA electronic-submission guidance and does not by itself determine which dataset standard is required for every study; current catalog and conformance requirements still govern.
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.
FDA’s current eCTD table-of-contents hierarchy places clinical study reports and related information under Module 5 section 5.3 and provides structured headings for the report and associated materials. This guide describes FDA eCTD organization, not the substantive clinical content required for every study or every jurisdiction.
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.
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 eCTD hierarchy includes a Study report body heading mapped to ICH E3 sections 1 and 3 through 15, separate from the synopsis and specified appendix or supporting-document headings. This page is scoped to FDA eCTD placement and naming; other submission systems or regional implementations can differ.
