定义中央监测能力：分享TransCelerate生物制药公司方法的经验，第2部分。
Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma's Approach, Part 2.
作者信息
Gough Jacqueline, Wilson Brett, Zerola Mireille, Wallis Phil, Mork Laila, Knepper David, Achenbach Heather
机构信息
1 Clinical Risk Management, Eli Lilly and Company, Indianapolis, IN, USA.
2 Global Development Operations, Research & Development, Bristol-Myers Squibb, Princeton, NJ, USA.
出版信息
Ther Innov Regul Sci. 2016 Jan;50(1):8-14. doi: 10.1177/2168479015618696.
BACKGROUND
TransCelerate's model approach to risk-based monitoring (RBM) includes the application of the appropriate monitoring activities to enable both the early detection and timely resolution of issues. This article is a follow-up to part 1, published in the September 2014 issue with the same title.
METHODS
The intent of this paper is to share information on what has been learned by various companies' applications of central monitoring activities based on different RBM operating models. A library of risk indicators has been created, and this paper provides additional guidance on what has been learned in the application of these tools.
RESULTS
The goal is to share the needs related to people, process, and technology as experienced by TransCelerate member companies.
CONCLUSIONS
One of the primary issue detection methods of central monitoring is the proactive identification of areas of focus through the use of risk indicators.
背景
跨速公司基于风险的监测（RBM）模型方法包括应用适当的监测活动，以实现问题的早期发现和及时解决。本文是2014年9月发表的同名第1部分的后续文章。
方法
本文旨在分享各公司基于不同RBM运营模式应用中央监测活动所获得的经验。已创建了一个风险指标库，本文就这些工具的应用经验提供了更多指导。
结果
目标是分享跨速公司成员在人员、流程和技术方面的相关需求。
结论
中央监测的主要问题检测方法之一是通过使用风险指标主动识别重点领域。
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