Development and evaluation of AI/ML-based tools for healthcare and medicine
Protocol template
A good protocol is the backbone of a good study. It’s scientific best practice, and expected by regulatory authorities, data stewards, and ethics boards.
Yet, standard protocol templates for medical research often work poorly for studies developing or evaluating AI/ML-enabled tools. Some “mandatory” sections are irrelevant and, at the same time, there’s no good place to specify important details.
This is an early draft of a template specifically designed for AI/ML-focused studies in healthcare and medicine. It is a work progress — feedback and ideas about how to improve it are very much appreciated!
Version
0.0
Date
17 June 2025
Get in touch.
Kathryn Rough, ScD, ScM
Email: info@kathrynrough.net
Phone: +49 176-40491566