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.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Use the CSR Data Sets Analyzed subsection to state exactly which patients entered each analysis and explain important exclusions or departures from the planned analysis set.
Key details
Core IssueICH 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.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
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.
Further guidance
Content
Define each analyzed set in results-stage terms, explain how analysis exclusions arose when necessary, and provide the supporting exclusion listing called for by the guidance.
Purpose
Use the CSR Data Sets Analyzed subsection to state exactly which patients entered each analysis and explain important exclusions or departures from the planned analysis set.
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 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 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 section 11.4.2.2 calls for the methods used to address dropouts and missing observations in efficacy analysis to be described and justified. This is the CSR results-analysis treatment of missing efficacy data; it does not replace the broader protocol or statistical-analysis-plan description of prespecified methods.
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 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 section 11.4.2.3 calls for interim analyses and data-monitoring activity relevant to the study results to be identified, including their timing, role, and implications for interpretation. Keep this CSR results/reporting scope separate from a general methods-only discussion of stopping rules or trial-governance policy.
ICH E3 section 12.4 calls for evaluation of laboratory data with attention to values over time, individual patient changes, and clinically significant abnormalities. The required detail depends on the study and reviewing authority; do not treat every laboratory measurement as equally important or duplicate raw listings in narrative form.
ICH E3 describes different levels of report detail: important summary figures and tables may appear in the text, other summary material in section 14, specified patient listings in Appendix 16.2, and U.S. archival individual-patient data in Appendix 16.4. This is an ICH E3 report-organization principle; the exact submission package and regional requirements can differ by authority.
