CONSORT-AI Checklist
Interactive reporting checklist for clinical trials involving artificial intelligence and machine learning.
CONSORT 2010 items only
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Items Rated
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Reported
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Not Reported
0
N/A
0
Unrated
CONSORT-AI items only
0%
Items Rated
0
Reported
0
Not Reported
0
N/A
0
Unrated
Combined
0%
Items Rated
0
Reported
0
Not Reported
0
N/A
0
Unrated
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, authors, editors and reviewers can systematically evaluate whether a trial report transparently describes critical AI-specific elements.
How the item tags work
Items shown under a CONSORT 2010 label are core trial-reporting items that apply to any randomised trial. Items shown under a CONSORT-AI label carry one of two tags: an Extension item is a wholly new reporting requirement that applies only to AI interventions, while an Elaboration item is an existing CONSORT 2010 requirement that needs additional detail when the intervention involves AI. Both designations are taken from the CONSORT-AI publication and are not editorial additions.
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 item wording is reproduced from CONSORT 2010 and CONSORT-AI. Explanations for the CONSORT-AI items are reproduced from the CONSORT-AI publication; explanations for the CONSORT 2010 items were written for this tool. Licensing terms for each source are noted below.
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 — reproduction permitted with attribution. Checklist item wording is reproduced unaltered; explanations for the AI-specific items are reproduced from the same source; explanations for the base-guideline items were written for this tool.
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.
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, authors, editors and reviewers can systematically evaluate whether a trial report transparently describes critical AI-specific elements.
How the item tags work
Items shown under a CONSORT 2010 label are core trial-reporting items that apply to any randomised trial. Items shown under a CONSORT-AI label carry one of two tags: an Extension item is a wholly new reporting requirement that applies only to AI interventions, while an Elaboration item is an existing CONSORT 2010 requirement that needs additional detail when the intervention involves AI. Both designations are taken from the CONSORT-AI publication and are not editorial additions.
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 item wording is reproduced from CONSORT 2010 and CONSORT-AI. Explanations for the CONSORT-AI items are reproduced from the CONSORT-AI publication; explanations for the CONSORT 2010 items were written for this tool. Licensing terms for each source are noted below.
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 — reproduction permitted with attribution. Checklist item wording is reproduced unaltered; explanations for the AI-specific items are reproduced from the same source; explanations for the base-guideline items were written for this tool.
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.
