SmartState: An Automated Research Protocol Adherence System.

Abstract

Developing and enforcing study protocols is crucial in medical research, especially as interactions with participants become more intricate. Traditional rules-based systems struggle to provide the automation and flexibility required for real-time, personalized data collection. We introduce SmartState, a state-based system designed to act as a personal agent for each participant, continuously managing and tracking their unique interactions. Unlike traditional reporting systems, SmartState enables real-time, automated data collection with minimal oversight. By integrating large language models to distill conversations into structured data, SmartState reduces errors and safeguards data integrity through built-in protocol and participant auditing. We demonstrate its utility in research trials involving time-dependent participant interactions, addressing the increasing need for reliable automation in complex clinical studies.