Clinical Study Reports and Related Information in eCTD Module 5
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.
ReviewedEvidence2 sourcesSectionWriting & Style
Quick answer
Organize a U.S. eCTD clinical-study submission under the applicable Module 5 hierarchy rather than treating the CSR as a single undifferentiated file bucket.
Key details
Core IssueFDA’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.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This guide describes FDA eCTD organization, not the substantive clinical content required for every study or every jurisdiction.
Further guidance
Content
Map the study report and related supporting files to the applicable Module 5 study category and document headings shown in the supported FDA eCTD hierarchy.
Purpose
Organize a U.S. eCTD clinical-study submission under the applicable Module 5 hierarchy rather than treating the CSR as a single undifferentiated file bucket.
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.
ICH E3 places representative written information for subjects and sample informed-consent forms among the ethics-supporting materials in appendix 16.1.3. The page concerns representative/sample materials under ICH E3; it does not claim that individual signed consent forms belong in the CSR or that one form satisfies every jurisdiction.
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.
ICH E3 section 12.3.3 calls for analysis and discussion across deaths, other serious adverse events, and other significant adverse events after the relevant case listings and narratives. This is an interpretive synthesis, not a duplicate death/serious-event listing or a replacement for individual patient narratives.
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.
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.
ICH E3 Section 13 calls for a concise discussion of efficacy and safety results, the risk-benefit relationship, unexpected findings, clinical relevance, unresolved issues, and implications for future studies without merely repeating results or introducing new ones. This section interprets results already presented; it should not simply duplicate result tables and should not introduce new study results that were not reported elsewhere.
ICH E3 section 11.4.4 addresses relationships among dose, measured drug concentration, and clinical response when those data are relevant to interpreting efficacy. This results-level relationship analysis is distinct from documenting how doses were selected or how concentrations were measured during study conduct.
