ICH E3 section 12.4.2 states that normal laboratory ranges should be given for each laboratory analysis alongside appropriate treatment-control comparisons. This page covers the explicit normal-range requirement in ICH E3 12.4.2; it does not replace the broader laboratory evaluation or patient-level listings.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
State the normal laboratory range used for each analysis so treatment-group comparisons and abnormality interpretations have an explicit reference context.
Key details
Core IssueICH E3 section 12.4.2 states that normal laboratory ranges should be given for each laboratory analysis alongside appropriate treatment-control comparisons.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This page covers the explicit normal-range requirement in ICH E3 12.4.2; it does not replace the broader laboratory evaluation or patient-level listings.
Further guidance
Content
Provide the relevant normal range alongside each laboratory analysis and keep the range definition consistent with the measurement context and reporting convention used.
Purpose
State the normal laboratory range used for each analysis so treatment-group comparisons and abnormality interpretations have an explicit reference context.
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 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 12.4.2 calls for evaluation of each laboratory parameter, with treatment and control groups compared as appropriate and normal laboratory ranges supplied for each analysis. This is the analytical layer under ICH E3 12.4.2; it is distinct from the patient-level raw/listing appendix and from a generic laboratory-data overview.
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 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 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.
FDA’s June 2026 guide says reference ranges should generally be provided for each laboratory result and unit, with appropriate ranges for relevant subpopulations such as pediatric subjects.
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 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.
