Estimated and Derived Values in Clinical Study Report Displays
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.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Mark estimated or derived values conspicuously in CSR displays and explain how they were produced and which assumptions underlie them.
Key details
Core IssueICH 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.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
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.
Further guidance
Content
Use labels, notes, or accompanying explanation sufficient for a reviewer to distinguish observed data from estimated or derived values and understand the derivation.
Purpose
Mark estimated or derived values conspicuously in CSR displays and explain how they were produced and which assumptions underlie them.
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 12.3.3 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 emphasizes that analyses, tables, and figures should clearly identify the set of patients from which the displayed result was generated. This is a results-display identification rule, not a substitute for prospectively defining analysis populations in a protocol or statistical analysis plan.
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 13 calls for a concise discussion of efficacy and safety results, the risk-benefit relationship, unexpected findings, clinical relevance, unresolved issues, and implications for future studies without merely repeating results or introducing new ones. This section interprets results already presented; it should not simply duplicate result tables and should not introduce new study results that were not reported elsewhere.
ICH E3 section 11.4.4 addresses relationships among dose, measured drug concentration, and clinical response when those data are relevant to interpreting efficacy. This results-level relationship analysis is distinct from documenting how doses were selected or how concentrations were measured during study conduct.
ICH E3 section 11.4.5 calls for efficacy discussion of drug-drug and drug-disease interactions when they are relevant to the study findings. Do not turn the subsection into a general pharmacology interaction catalogue; keep it tied to interactions evaluated or observed in the reported clinical study.
ICH E3 Section 9.5 calls for identification of the efficacy and safety variables assessed, the methods and timing of assessments, and the people or procedures responsible for measurements, often with a schedule or flow chart. This section defines variables and assessment methods; it is not the same artifact as the later efficacy or safety result tables.
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.
