FAIRsharing record for: Standard Protocol Items: Recommendations for Interventional Trials–Artificial Intelligence

This FAIRsharing record describes: The SPIRIT-AI extension is a set of recommendations for clinical trial protocols evaluating interventions with an AI component. SPIRIT-AI includes 15 new items which should be routinely reported in addition to the core SPIRIT 2013 items. The checklist recommends that investigators provide clear descriptions of the AI intervention, prior evidence supporting the validation of the AI intervention, the proposed trial setting in which the AI intervention will be evaluated, specifying how the input and outputs of the AI intervention will be handled and description of the intended human-AI interaction during the trial.