Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension

Scope: This document pertains to the reporting of clinical trial protocols for studies evaluating interventions that include an artificial intelligence component.

Reference: See source/variants/spirit-ai.yml for canonical link and provenance.

Instructions

• Use the boxes to confirm each reporting item.
• Add reviewer notes under each section as needed.

Checklist Items

• Item 1: Title - Indicate that the trial involves AI.
• Item 2: Abstract - Provide a structured summary of the protocol.

Notes

Reviewer notes

Provenance

• Source: See sidecar metadata in source/variants/spirit-ai.yml
• Version: 2020
• License: CC-BY-4.0