A new risk and issue management system to improve productivity, quality, and compliance in clinical trials

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Abstract

Objective: We present a new system to track, manage, and report on all risks and issues encountered during a clinical trial. Materials and Methods: Our solution utilizes JIRA, a popular issue and project tracking tool for software development, augmented by third-party and custom-built plugins to provide the additional functionality missing from the core product. Results: The new system integrates all issue types under a single tracking tool and offers a range of capabilities, including configurable issue management workflows, seamless integration with other clinical systems, extensive history, reporting, and trending, and an intuitive web interface. Discussion and Conclusion: By preserving the linkage between risks, issues, actions, decisions, and outcomes, the system allows study teams to assess the impact and effectiveness of their risk management strategies and present a coherent account of how the trial was conducted. Since the tool was put in production, we have observed an increase in the number of reported issues and a decrease in the median issue resolution time which, along with the positive user feedback, point to marked improvements in quality, transparency, productivity, and teamwork.

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APA

Ciervo, J., Shen, S. C., Stallcup, K., Thomas, A., Farnum, M. A., Lobanov, V. S., & Agrafiotis, D. K. (2019). A new risk and issue management system to improve productivity, quality, and compliance in clinical trials. JAMIA Open, 2(2), 216–221. https://doi.org/10.1093/jamiaopen/ooz006

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