Development of a risk assessment and risk management tool for an academic research organization.
Development of a risk assessment and risk management tool for an academic research organization.
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DOI：
10.1016/j.cct.2022.106812
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发表时间：
2022-08
影响因子：
2.2
通讯作者：
Brulotte, Maryse
中科院分区：
文献类型：
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作者：
VanBuren, John M.;Roalstad, Shelly;Kay, Marie T.;Zuspan, Sally Jo;Dean, J. Michael;Brulotte, Maryse
在过去的十年中，监管机构发布了有关基于风险的管理的指南，其目标是重点关注研究关键方面的风险。为了实施这些指导方针，已经开发了几种工具。我们设计了一个风险管理工具来满足学术数据协调中心的需求。我们根据风险/质量计划的三个基本标准开发了风险评估和风险管理 (RARM) 工具： (1) 质量源于设计概念适用于所有员工，无论员工的角色如何； (2) RARM过程在研究启动和实施过程中必须具有经济可行性和动态灵活性； (3) RARM 的责任在于整个研究团队，而不是单一的质量专家。 RARM 工具有 20 个用于风险评估和风险管理的要素。风险管理两个方面的结合可以实现从识别风险到在整个注册过程中主动监控风险的无缝过渡。 RARM 工具实现了一种简化、无缝的风险评估和风险管理方法。该工具通过让每个团队成员为 RARM 工具做出贡献，将质量源于设计的概念融入到日常工作中。它还将风险评估和风险管理流程结合到一个工具中，从而可以在整个研究周期中实现从识别风险到管理风险的无缝过渡。这些说明有助于在开发早期记录去风险协议，并且该工具可以在任何平台和组织中实施。
In the past decade, regulatory agencies have released guidance around risk-based management with the goal of focusing on risks to critical aspects of a research study. Several tools have been developed aimed at implementing these guidelines. We designed a risk management tool to meet the demands of our academic data coordinating center. We developed the Risk Assessment and Risk Management (RARM) tool on three fundamental criteria of our risk/quality program: (1) Quality by Design concepts applies to all employees, regardless of the employee’s role; (2) the RARM process must be economically feasible and dynamically flexible during the study startup and implementation process; and (3) responsibility of the RARM lay with the entire study team as opposed to a single quality expert. The RARM tool has 20 elements for both risk assessment and risk management. The incorporation of both aspects of risk management allow for a seamless transition from identifying risks to actively monitoring risks throughout enrollment. The RARM tool achieves a simplified, seamless approach to risk assessment and risk management. The tool incorporates the concept of Quality by Design into daily work by having every team member contribute to the RARM tool. It also combines the risk assessment and risk management processes into a single tool which allows for a seamless transition from identifying risks to managing the risks throughout the life of the study. The instructions facilitate documentation of de-risking protocols early in development and the tool can be implemented in any platform and organization.
影响因子：
2.1
作者：
Ciervo, Joseph;Shen, Shih Chuan;Agrafiotis, Dimitris K.
通讯作者：
Agrafiotis, Dimitris K.
影响因子：
1.5
作者：
Suprin, Melissa;Chow, Allan;Tomlin, Irene
通讯作者：
Tomlin, Irene
影响因子：
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作者：
Landray, Martin J.;Grandinetti, Cheryl;Sherman, Rachel E.
通讯作者：
Sherman, Rachel E.