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

Autor:	Ciervo J; Covance, the Drug Development Division of LabCorp, Princeton, New Jersey, USA., Shen SC; Covance, the Drug Development Division of LabCorp, Princeton, New Jersey, USA., Stallcup K; Covance, the Drug Development Division of LabCorp, Princeton, New Jersey, USA., Thomas A; Covance, the Drug Development Division of LabCorp, Princeton, New Jersey, USA., Farnum MA; Covance, the Drug Development Division of LabCorp, Princeton, New Jersey, USA., Lobanov VS; Covance, the Drug Development Division of LabCorp, Princeton, New Jersey, USA., Agrafiotis DK; Covance, the Drug Development Division of LabCorp, Princeton, New Jersey, USA.
Jazyk:	angličtina
Zdroj:	JAMIA open [JAMIA Open] 2019 Mar 19; Vol. 2 (2), pp. 216-221. Date of Electronic Publication: 2019 Mar 19 (Print Publication: 2019).
DOI:	10.1093/jamiaopen/ooz006
Abstrakt:	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. (© The Author(s) 2019. Published by Oxford University Press on behalf of the American Medical Informatics Association.)
Databáze:	MEDLINE
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