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. 2025 Jun 10:2025:56-64.
eCollection 2025.

SmartState: An Automated Research Protocol Adherence System

Samuel E Armstrong  1 , Mitchell A Klusty  1 , Aaron D Mullen  1 , Jeffery C Talbert  1 , Cody Bumgardner  1
Affiliations

SmartState: An Automated Research Protocol Adherence System

Samuel E Armstrong et al. AMIA Jt Summits Transl Sci Proc. .

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.

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Figures

Figure 1.
Figure 1.
Overview of SmartState components and their interactions.
Figure 2.
Figure 2.
An example finite state machine graph for booking an airline seat.
Figure 3.
Figure 3.
State machine graph handling user input. If the response is not satisfactory, add context and ask the question again.
Figure 4.
Figure 4.
(a) State machine displayed as a graph with audit logs of states entered and transitions. (b) Message logs for a specific participant.
Figure 5.
Figure 5.
Example workflow for a conversation with a participant verifying the use of a beta blocker.
Figure 6.
Figure 6.
(a) Simplified state-based interaction for start and end calorie messages. (b) Full protocol state graph.
See this image and copyright information in PMC

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