ICH E3 appendix 16.1.5 addresses signatures of principal or coordinating investigators, or of the sponsor’s responsible medical officer, where required by the applicable regulatory authority. ICH E3 makes this item authority-dependent; this guide therefore does not claim that the same signature configuration is mandatory for every CSR or jurisdiction.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
The signature appendix records formal responsibility or attestation associated with the CSR without replacing the separate investigator-list appendix.
Key details
Core IssueICH E3 appendix 16.1.5 addresses signatures of principal or coordinating investigators, or of the sponsor’s responsible medical officer, where required by the applicable regulatory authority.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
ICH E3 makes this item authority-dependent; this guide therefore does not claim that the same signature configuration is mandatory for every CSR or jurisdiction.
Further guidance
Content
Place the applicable signature material in the designated appendix when the governing authority requires it, using the signatory role contemplated by ICH E3 and local submission requirements.
Purpose
The signature appendix records formal responsibility or attestation associated with the CSR without replacing the separate investigator-list appendix.
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 16.1.4 calls for a list and description of investigators and other important participants, with brief curricula vitae or equivalent summaries of relevant training and experience. This CSR appendix is not the same as a general investigator-oversight plan and does not redefine local credentialing, delegation, privacy, or regulatory requirements.
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 11.4.2.7 identifies special efficacy-analysis considerations for active-control studies intended to support equivalence. This is a CSR efficacy-results reporting issue for active-control equivalence designs; it does not define a universal equivalence margin or replace protocol-level design justification.
ICH E3 section 11.4.2.1 calls for covariate or prognostic-factor selection and adjustment to be explained, including adjustment methods, analysis results, supportive statistical documentation, and differences from planned analyses when relevant. This results-stage statistical issue is narrower than the general statistical-methods section and should not be used as a substitute for documenting the full analysis plan.
ICH E3 places patient-level adverse-event listings in the report appendices and calls for listings that identify individual patients and relevant event details supporting review. A listing is not the same as a summary adverse-event table or a selected patient narrative; each serves a different level of safety reporting.
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 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.
