Investigational Product Batch Listing in Clinical Study Report
ICH E3 appendix 16.1.6 calls for a listing of subjects who received specific investigational-product test-drug batches when more than one batch was used. This appendix is conditional on the use of more than one relevant batch and is distinct from broader investigational-product accountability, dose, and exposure narratives.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
The batch listing supports traceability between study subjects and the investigational-product batches they received.
Key details
Core IssueICH E3 appendix 16.1.6 calls for a listing of subjects who received specific investigational-product test-drug batches when more than one batch was used.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This appendix is conditional on the use of more than one relevant batch and is distinct from broader investigational-product accountability, dose, and exposure narratives.
Further guidance
Content
When multiple relevant test-drug batches were used, provide the subject-to-batch listing in the designated appendix so batch exposure can be traced at the patient level.
Purpose
The batch listing supports traceability between study subjects and the investigational-product batches they received.
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 16.2.1 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 9.4.2 calls for identification of the investigational/test product and relevant comparator or placebo information in the report. Report product identity at the level needed by ICH E3; do not turn this subsection into a general manufacturing dossier or duplicate unrelated product-quality documentation.
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 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.
ICH E3 appendix 16.2.2 identifies a patient-level protocol-deviations listing, while the E3 Q&A clarifies the meaning of protocol deviation and important protocol deviation. This appendix-level listing is distinct from a general protocol-deviations narrative section, and classification should follow the study’s applicable definitions rather than an invented universal threshold.
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.
