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AI4HM: A Protocol Template for Observational Studies Involving Artificial Intelligence and Machine Learning in Health and Medicine

Artificial intelligence/machine learning

Current protocol templates for pharmacoepidemiology RWE studies are optimized for hypothesis-evaluating studies with pre-specified analyses and well-defined study components e.g., ENCEPP, HARPER. However, they do not adequately address the iterative development, validation, and deployment considerations unique to AI/ML-based health research Registered: 26 July 2026

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Contact: Nivantha Naidoo Email: [email protected]