Representative Subject Information and Consent Forms in Clinical Study Report
ICH E3 places representative written information for subjects and sample informed-consent forms among the ethics-supporting materials in appendix 16.1.3. The page concerns representative/sample materials under ICH E3; it does not claim that individual signed consent forms belong in the CSR or that one form satisfies every jurisdiction.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
This appendix preserves representative materials that show what subjects were told and the form of consent documentation used for the study.
Key details
Core IssueICH E3 places representative written information for subjects and sample informed-consent forms among the ethics-supporting materials in appendix 16.1.3.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
The page concerns representative/sample materials under ICH E3; it does not claim that individual signed consent forms belong in the CSR or that one form satisfies every jurisdiction.
Further guidance
Content
Include representative subject-facing written information, when used, together with the sample informed-consent form in the designated CSR appendix rather than reproducing individual signed consent records.
Purpose
This appendix preserves representative materials that show what subjects were told and the form of consent documentation used for the study.
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 places a sample case report form among study-information appendices and calls for submitted case report forms for deaths, other serious adverse events, and withdrawals due to adverse events in the designated appendix area. Case report forms are source/reporting documents, not the same artifact as summary tables, patient-data listings, or narrative case descriptions.
FDA’s current eCTD table-of-contents hierarchy places clinical study reports and related information under Module 5 section 5.3 and provides structured headings for the report and associated materials. This guide describes FDA eCTD organization, not the substantive clinical content required for every study or every jurisdiction.
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 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.
