AfCAI Association for Clinical Artificial Intelligence

CONSORT-AI Checklist

Interactive reporting checklist for clinical trials involving artificial intelligence and machine learning.

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CONSORT 2010 core items only
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CONSORT-AI extension only
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About This Tool: The CONSORT-AI Checklist

What is it for?
This tool is a web-based checklist implementing the CONSORT-AI (Consolidated Standards of Reporting Trials–Artificial Intelligence) extension. Its primary purpose is to serve as a reporting completeness checklist for clinical trials evaluating interventions that involve artificial intelligence or machine learning. Developed by an international multi-stakeholder group, CONSORT-AI introduces 14 AI-specific items (11 extensions and 3 elaborations) that are used alongside the standard CONSORT 2010 core items. By using this checklist, reviewers can systematically evaluate whether a trial report transparently describes critical AI-specific elements.

This web tool is provided for educational and review purposes only and does not constitute formal editorial, regulatory, methodological, clinical, or legal advice. Please consult the original publications for the full official guidance.

Sources and attribution
Checklist items are derived from CONSORT 2010 and CONSORT-AI. Explanatory summaries have been independently rewritten for educational and review purposes.

1. Liu, X., Cruz Rivera, S., Moher, D. et al. Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension. Nat Med 26, 1364–1374 (2020). doi:10.1038/s41591-020-1034-x. Published under CC BY 4.0.
2. Moher, D., Hopewell, S., Schulz, K.F. et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 340, c869 (2010). doi:10.1136/bmj.c869. Correction: BMJ 343, d6131 (2011).
This checklist is not endorsed by the original authors.