Individual Efficacy Response Data Listing in Clinical Study Report
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.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
The listing exposes individual efficacy response data that underlie or complement the report’s summarized efficacy results.
Key details
Core IssueICH E3 appendix 16.2.6 designates individual efficacy response data as a patient-level listing in the clinical study report supporting material.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This is a patient-level listing function, not a substitute for aggregate efficacy tables, statistical analyses, or the broader individual-patient-data appendix overview.
Further guidance
Content
Present the required patient-level efficacy response data in the designated listing so individual observations can be reviewed alongside aggregate efficacy analyses.
Purpose
The listing exposes individual efficacy response data that underlie or complement the report’s summarized efficacy results.
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 appendix 16.2.8 addresses listings of individual laboratory measurements by patient when such listings are required by regulatory authorities. ICH E3 makes these patient-level listings conditional on regulatory requirements; this page does not imply that every CSR must include the same laboratory appendix.
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 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.
ICH E3 section 12.4.1 points to a by-patient listing of abnormal laboratory values in section 14.3.4 and distinguishes that safety display from the broader listing of individual laboratory measurements. This page is about the dedicated abnormal-value listing under ICH E3 14.3.4; it is distinct from the full individual-measurement appendix under 16.2.8 and from analytical discussion in section 12.4.2.
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.
ICH E3 appendix 16.2.1 identifies a patient-level listing for discontinued patients as part of the clinical study report’s individual-patient data appendices. The exact categories and reasons should follow the study protocol and applicable submission conventions; this page does not impose one universal discontinuation taxonomy.
