Evaluation of Each Laboratory Parameter in Clinical Study Report
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.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Use this subsection to evaluate each relevant laboratory parameter with treatment-control comparisons where appropriate, rather than merely listing measurements.
Key details
Core IssueICH 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.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
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.
Further guidance
Content
Present the analyses required by the observed laboratory results, including suitable treatment-control comparison and the normal range used for interpretation.
Purpose
Use this subsection to evaluate each relevant laboratory parameter with treatment-control comparisons where appropriate, rather than merely listing measurements.
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 9.4.5 addresses rules or methods used to select the dose and timing of dose for individual patients. This is the patient-level dosing procedure subsection, not the preceding rationale for selecting the study doses or the later results analysis of dose-response relationships.
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 12.3.3 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.
ICH E3 section 9.5.2 calls for discussion of the appropriateness, reliability, or relevance of measurements used to assess efficacy and safety when explanation is needed. This subsection justifies or qualifies measurement choices; it does not replace the section that defines the variables, methods, and timing of assessments.
ICH E3 section 12.2.1 calls for a brief summary of adverse events within the safety evaluation before more detailed displays and analyses. Keep this section a high-level summary; it is not a substitute for detailed adverse-event displays, patient-level listings, serious-event treatment, or narratives.
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 section 9.2 calls for discussion of the chosen control and study design, including design problems or biases that may matter for interpretation. This guide concerns the rationale and limitations of the control/design choice; the Study Design guide owns the descriptive overview of the study configuration itself.
