ICH E3 directs the clinical study report to identify the independent ethics committees or institutional review boards consulted, with the supporting list placed in appendix 16.1.3. This appendix-level list is distinct from the main ethics discussion and from representative subject-information or consent-form materials that may share the same appendix grouping; exact local requirements remain authority-dependent.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
The IEC or IRB List documents the ethics-review bodies associated with the study so a reader can locate that supporting oversight information without overloading the main report narrative.
Key details
Core IssueICH E3 directs the clinical study report to identify the independent ethics committees or institutional review boards consulted, with the supporting list placed in appendix 16.1.3.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This appendix-level list is distinct from the main ethics discussion and from representative subject-information or consent-form materials that may share the same appendix grouping; exact local requirements remain authority-dependent.
Further guidance
Content
Provide the IEC/IRB identification required by the governing CSR guidance in the designated appendix, including chair information where the applicable authority requires it.
Purpose
The IEC or IRB List documents the ethics-review bodies associated with the study so a reader can locate that supporting oversight information without overloading the main report narrative.
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 9.8 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 11.4.2.2 calls for the methods used to address dropouts and missing observations in efficacy analysis to be described and justified. This is the CSR results-analysis treatment of missing efficacy data; it does not replace the broader protocol or statistical-analysis-plan description of prespecified methods.
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 15 calls for a reference list of literature pertinent to evaluation of the study and directs that important publications be attached in the designated appendices. This is the ICH E3 section 15 reference list for the clinical study report; it is not a generic bibliography-versus-reference-list style question.
ICH E3 section 9.3.3 identifies Removal of Patients from Therapy or Assessment as a planned study-population subsection of the investigational plan. This subsection states planned removal criteria or procedures; it is not the same as the results-stage disposition of patients or a listing of patients who actually discontinued.
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.
