Individual Laboratory Measurements Listing in Clinical Study Report
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.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
The appendix makes patient-level laboratory measurements available for regulatory review beyond the aggregate laboratory summaries in the CSR body.
Key details
Core IssueICH E3 appendix 16.2.8 addresses listings of individual laboratory measurements by patient when such listings are required by regulatory authorities.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
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.
Further guidance
Content
When the governing authority requires patient-level laboratory listings, place the individual measurements in the designated appendix with identifiers and structure appropriate to the submission.
Purpose
The appendix makes patient-level laboratory measurements available for regulatory review beyond the aggregate laboratory summaries in the CSR body.
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 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 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 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 9.5.4 identifies drug concentration measurements as a distinct investigational-plan subsection when such measurements are part of the study. This methods subsection is distinct from patient-level laboratory-data listings and from later analyses relating dose or concentration to clinical response.
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 section 12.4.2.3 calls for discussion and analysis of individual clinically significant laboratory abnormalities, including assessment of clinical significance and likely treatment relationship. This is not a listing of every abnormal value: the focus is on clinically significant changes and their interpretation within the ICH E3 safety framework.
