Interactive checklist for clinical trial protocols of interventions involving artificial intelligence and machine learning.
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, investigators, editors and reviewers can systematically evaluate whether a trial protocol 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 SPIRIT 2013 and SPIRIT-AI. Explanatory summaries have been independently rewritten for educational and review purposes.
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.
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.