SPIRIT-AI Checklist
Interactive checklist for clinical trial protocols of interventions involving artificial intelligence and machine learning.
SPIRIT 2013 items only
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Items Rated
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Not Reported
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Unrated
SPIRIT-AI items only
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Items Rated
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Reported
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Not Reported
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N/A
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Unrated
Combined
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Items Rated
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Reported
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Not Reported
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Unrated
About This Tool: The SPIRIT-AI Checklist
What is it for?
This tool is a web-based checklist implementing the SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials – Artificial Intelligence) extension. Its primary purpose is to serve as a completeness checklist for clinical trial protocols of interventions that involve artificial intelligence or machine learning. Developed by an international multi-stakeholder group, SPIRIT-AI introduces 15 AI-specific items (12 extensions and 3 elaborations) that are addressed alongside the core SPIRIT 2013 protocol items. By using this checklist, authors, editors and reviewers can systematically evaluate whether a trial protocol transparently describes critical AI-specific elements.
How the item tags work
Items shown under a SPIRIT 2013 label are core protocol items that apply to any clinical trial. Items shown under a SPIRIT-AI label carry one of two tags: an Extension item is a wholly new protocol requirement that applies only to AI interventions, while an Elaboration item is an existing SPIRIT 2013 requirement that needs additional detail when the intervention involves AI. Both designations are taken from the SPIRIT-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 SPIRIT 2013 and SPIRIT-AI. Explanations for the SPIRIT-AI items are reproduced from the SPIRIT-AI publication; explanations for the SPIRIT 2013 items were written for this tool. Licensing terms for each source are noted below.
1. Cruz Rivera, S., Liu, X., Chan, A.W., Denniston, A.K., Calvert, M.J., et al. Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension. Nat Med 26, 1351–1363 (2020). doi:10.1038/s41591-020-1037-7 (also published as BMJ 2020;370:m3210, doi:10.1136/bmj.m3210). 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. Chan, A.W., Tetzlaff, J.M., Gøtzsche, P.C. et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 346, e7586 (2013). doi:10.1136/bmj.e7586.
This checklist is not endorsed by the original authors.
What is it for?
This tool is a web-based checklist implementing the SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials – Artificial Intelligence) extension. Its primary purpose is to serve as a completeness checklist for clinical trial protocols of interventions that involve artificial intelligence or machine learning. Developed by an international multi-stakeholder group, SPIRIT-AI introduces 15 AI-specific items (12 extensions and 3 elaborations) that are addressed alongside the core SPIRIT 2013 protocol items. By using this checklist, authors, editors and reviewers can systematically evaluate whether a trial protocol transparently describes critical AI-specific elements.
How the item tags work
Items shown under a SPIRIT 2013 label are core protocol items that apply to any clinical trial. Items shown under a SPIRIT-AI label carry one of two tags: an Extension item is a wholly new protocol requirement that applies only to AI interventions, while an Elaboration item is an existing SPIRIT 2013 requirement that needs additional detail when the intervention involves AI. Both designations are taken from the SPIRIT-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 SPIRIT 2013 and SPIRIT-AI. Explanations for the SPIRIT-AI items are reproduced from the SPIRIT-AI publication; explanations for the SPIRIT 2013 items were written for this tool. Licensing terms for each source are noted below.
1. Cruz Rivera, S., Liu, X., Chan, A.W., Denniston, A.K., Calvert, M.J., et al. Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension. Nat Med 26, 1351–1363 (2020). doi:10.1038/s41591-020-1037-7 (also published as BMJ 2020;370:m3210, doi:10.1136/bmj.m3210). 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. Chan, A.W., Tetzlaff, J.M., Gøtzsche, P.C. et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 346, e7586 (2013). doi:10.1136/bmj.e7586.
This checklist is not endorsed by the original authors.
