ICH E3 includes measurements of treatment compliance in the efficacy evaluation and identifies compliance and/or drug-concentration data as a patient-level appendix listing. This is reporting guidance for an ICH E3 CSR; it does not define a universal adherence threshold or replace protocol-specific compliance definitions.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Treatment compliance reporting in a CSR explains how adherence to assigned treatment was assessed and presents the supporting compliance data needed to interpret efficacy and exposure.
Key details
Core IssueICH E3 includes measurements of treatment compliance in the efficacy evaluation and identifies compliance and/or drug-concentration data as a patient-level appendix listing.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This is reporting guidance for an ICH E3 CSR; it does not define a universal adherence threshold or replace protocol-specific compliance definitions.
Further guidance
Content
Describe the measurement method and summarize compliance in the core report, then provide patient-level compliance or drug-concentration detail in the relevant appendix listing when applicable.
Purpose
Treatment compliance reporting in a CSR explains how adherence to assigned treatment was assessed and presents the supporting compliance data needed to interpret efficacy and exposure.
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 9.4.3 calls for the specific method used to assign patients to treatment groups, including relevant allocation, stratification, or blocking features. This report-body method section is distinct from the detailed randomization scheme and codes placed in appendix 16.1.7 and should not imply randomization when the study used another assignment method.
ICH E3 section 9.4.1, Treatments Administered, describes the treatment regimens administered to study groups within the investigational plan. Keep the treatment-assignment description distinct from section 9.4.3, which explains the method used to assign patients to groups and from the randomization-scheme appendix.
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 11.4.2.7 identifies special efficacy-analysis considerations for active-control studies intended to support equivalence. This is a CSR efficacy-results reporting issue for active-control equivalence designs; it does not define a universal equivalence margin or replace protocol-level design justification.
ICH E3 section 11.4.2.1 calls for covariate or prognostic-factor selection and adjustment to be explained, including adjustment methods, analysis results, supportive statistical documentation, and differences from planned analyses when relevant. This results-stage statistical issue is narrower than the general statistical-methods section and should not be used as a substitute for documenting the full analysis plan.
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 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.
ICH E3 section 12.2.3 calls for analysis of adverse events beyond their tabular display, focusing on patterns important to safety interpretation. Do not treat the analysis as a substitute for the event display or patient-level listing, and do not imply causality beyond what the study evidence supports.
