Michele La Badie, ACRP-CP, MDP, PM, has spent her career at the intersection of data integrity and clinical research quality; first navigating the paper-to-EMR transition under the HITECH Act and Meaningful Use mandates, and later carrying that same focus into clinical research. As a Clinical Trial Manager at Shoulder Innovations and a contributing item writer for the ACRP MDP certification exam, Michele brings a medical device quality lens to AI implementation; whether at the research site or sponsor level. Her approach is grounded in a simple principle: AI doesn't eliminate quality risk, it relocates it. This presentation applies medical device research principles such as goal-setting, output monitoring, failure categorization, and threshold-setting, to the problem of AI oversight, offering a practical framework for building internal quality assurance programs that are rigorous, scalable, and grounded in methodology that clinical research already knows how to use.

Session:

• The ABCs of Quality Assurance When AI Comes to Town