A new risk and issue management system to improve productivity, quality, and compliance in clinical trials
A new risk and issue management system to improve productivity, quality, and compliance in clinical trials
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DOI：
10.1093/jamiaopen/ooz006
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发表时间：
2019-07-01
期刊：
影响因子：
2.1
通讯作者：
Agrafiotis, Dimitris K.
中科院分区：
文献类型：
--
作者：
Ciervo, Joseph;Shen, Shih Chuan;Agrafiotis, Dimitris K.
目的：我们提出一个新的系统来跟踪、管理和报告在临床试验中遇到的所有风险和问题。材料和方法：我们的解决方案利用JIRA，这是一种流行的软件开发问题和项目跟踪工具，通过第三方和定制的插件进行增强，以提供核心产品所缺少的额外功能。结果：新系统将所有问题类型集成在一个单一的跟踪工具下，并提供一系列功能，包括可配置的问题管理工作流，与其他临床系统的无缝集成，广泛的历史记录，报告和趋势，以及直观的web界面。讨论和结论：通过保留风险、问题、行动、决策和结果之间的联系，该系统允许研究团队评估其风险管理策略的影响和有效性，并对试验如何进行进行连贯的说明。自从该工具投入生产以来，我们观察到报告的问题数量有所增加，问题解决的中间时间有所减少，这与积极的用户反馈一起，表明了质量、透明度、生产力和团队合作方面的显著改进。
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.