U.S. Archival Individual Patient Data Listings in Clinical Study Report
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.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Keep U.S. archival individual-patient listings conceptually separate from the reviewer-focused Appendix 16.2 listings that support specified analyses.
Key details
Core IssueICH 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.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
The Appendix 16.4 archival-listing statement is explicitly U.S.-specific in ICH E3 and should not be generalized to every ICH region.
Further guidance
Content
Use the regional archival-listing category only when the applicable U.S. submission requirement calls for it, and do not treat it as the same artifact as every CSR patient listing.
Purpose
Keep U.S. archival individual-patient listings conceptually separate from the reviewer-focused Appendix 16.2 listings that support specified analyses.
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 uses appendices for individual-patient data listings that support critical analyses, including specified listings for disposition, deviations, demographics, efficacy, adverse events, and laboratory measurements. The exact listings and submission format can depend on the reviewing authority; this page is about the ICH E3 report function, not a universal requirement to publish raw patient data publicly.
ICH E3 appendix 16.2.6 designates individual efficacy response data as a patient-level listing in the clinical study report supporting material. This is a patient-level listing function, not a substitute for aggregate efficacy tables, statistical analyses, or the broader individual-patient-data appendix overview.
ICH E3 section 12.4.2.2 calls for analysis of individual patient laboratory changes by treatment group and gives several possible display approaches. This subsection focuses on within-patient change; it is distinct from group-level values-over-time summaries and from the raw measurement listing.
ICH E3 places patient-level adverse-event listings in the report appendices and calls for listings that identify individual patients and relevant event details supporting review. A listing is not the same as a summary adverse-event table or a selected patient narrative; each serves a different level of safety reporting.
ICH E3 section 11.4.6 identifies by-patient displays as a distinct part of efficacy evaluation for showing individual response information when useful. A by-patient efficacy display is not the same as the appendix listing of adverse events or a narrative case report; keep efficacy and safety purposes distinct.
ICH E3 section 9.6 calls for data quality assurance information relevant to the reliability and integrity of the reported study data. This CSR-specific section does not replace broader trial quality-management guidance and should not be conflated with the separate appendix for interlaboratory standardization documentation.
ICH E3 section 11.1 calls for the exact patients included in each efficacy analysis to be precisely defined and for relevant exclusions and their timing or rationale to be accounted for. This CSR subsection reports the sets actually analyzed; it is distinct from protocol-stage prespecification of analysis populations and from general study-population selection criteria.
ICH E3 calls for demographic and other baseline characteristics in the core efficacy evaluation and also identifies patient-level demographic data among the report’s appendix listings. This page is specific to ICH E3 clinical-study-report presentation and is distinct from general manuscript advice about a baseline-characteristics table.
