Annotated Case Report Form in Study Data Submission
FDA’s June 2026 conformance guide describes the annotated case report form (aCRF) as a PDF that maps clinical data-collection fields to corresponding variables or values in SDTM datasets. This is FDA standardized clinical study-data guidance and is distinct from the broader CSR appendix question of which case report forms belong in a report.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Submit the aCRF as the mapping document between collected CRF fields and the submitted SDTM representation.
Key details
Core IssueFDA’s June 2026 conformance guide describes the annotated case report form (aCRF) as a PDF that maps clinical data-collection fields to corresponding variables or values in SDTM datasets.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This is FDA standardized clinical study-data guidance and is distinct from the broader CSR appendix question of which case report forms belong in a report.
Further guidance
Content
Map CRF variables to corresponding dataset variables, include variable names and coding, and follow the current FDA PDF/file-naming guidance for the aCRF.
Purpose
Submit the aCRF as the mapping document between collected CRF fields and the submitted SDTM representation.
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 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.
ICH E3 section 9.6 calls for data quality assurance information relevant to the reliability and integrity of the reported study data. This CSR-specific section does not replace broader trial quality-management guidance and should not be conflated with the separate appendix for interlaboratory standardization documentation.
ICH E3 section 11.1 calls for the exact patients included in each efficacy analysis to be precisely defined and for relevant exclusions and their timing or rationale to be accounted for. This CSR subsection reports the sets actually analyzed; it is distinct from protocol-stage prespecification of analysis populations and from general study-population selection criteria.
FDA’s June 2026 conformance guide recommends sizing character-data columns to the maximum variable length used across study datasets, with a separate individual-dataset rule for SUPPQUAL datasets. This is current FDA technical-conformance guidance for study-data files; exact implementation must still follow the applicable supported data standard and submission format.
ICH E3 calls for demographic and other baseline characteristics in the core efficacy evaluation and also identifies patient-level demographic data among the report’s appendix listings. This page is specific to ICH E3 clinical-study-report presentation and is distinct from general manuscript advice about a baseline-characteristics table.
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 16.2.6 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 uses appendices for individual-patient data listings that support critical analyses, including specified listings for disposition, deviations, demographics, efficacy, adverse events, and laboratory measurements. The exact listings and submission format can depend on the reviewing authority; this page is about the ICH E3 report function, not a universal requirement to publish raw patient data publicly.
