Abnormal Laboratory Value Listing in Clinical Study Report
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.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Use the abnormal-laboratory-value listing to present patient-level abnormal laboratory results in the dedicated safety display area when required by the applicable submission framework.
Key details
Core IssueICH 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.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
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.
Further guidance
Content
Provide the by-patient abnormal-value listing with enough context to identify the measurement, patient, timing, and abnormality, and explain any rules used to exclude values from further analysis.
Purpose
Use the abnormal-laboratory-value listing to present patient-level abnormal laboratory results in the dedicated safety display area when required by the applicable submission framework.
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 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.
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 16.2.6 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 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 appendix 16.1.6 calls for a listing of subjects who received specific investigational-product test-drug batches when more than one batch was used. This appendix is conditional on the use of more than one relevant batch and is distinct from broader investigational-product accountability, dose, and exposure narratives.
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 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.
