Individual Patient Changes in Laboratory Values in Clinical Study Report
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.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Use this subsection to analyze within-patient laboratory changes by treatment group using suitable displays such as shift tables, threshold-change tables, or baseline-versus-treatment plots.
Key details
Core IssueICH E3 section 12.4.2.2 calls for analysis of individual patient laboratory changes by treatment group and gives several possible display approaches.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This subsection focuses on within-patient change; it is distinct from group-level values-over-time summaries and from the raw measurement listing.
Further guidance
Content
Choose a patient-change display that makes clinically meaningful shifts visible and explain any thresholds used to define notable change.
Purpose
Use this subsection to analyze within-patient laboratory changes by treatment group using suitable displays such as shift tables, threshold-change tables, or baseline-versus-treatment plots.
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 section 12.4.2.1 describes laboratory values over time using group summaries such as means or medians, ranges, and counts of abnormal values at study time points. This is a longitudinal laboratory-analysis subsection, not a substitute for patient-level laboratory listings or for analysis of individual patient shifts.
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 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 9.8 calls for changes made after the study began to the conduct of the study or planned analyses to be described, including timing, reasons, decision process, responsibility, available data, and interpretive implications as applicable. This section is broader than a statistical-methods subsection: it covers material study-conduct changes as well as planned-analysis changes, while detailed statistical methods remain in their dedicated section.
ICH E3 states that estimated or derived values used in a table, figure, or data listing should be conspicuously identified and their derivation and underlying assumptions explained. This display rule is broader than the patient-level listing guide: it applies across tables, figures, and data listings wherever estimated or derived values appear.
