Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development
Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development
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DOI：
10.1177/2168479018817752
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发表时间：
2019-01-01
影响因子：
1.5
通讯作者：
Tomlin, Irene
中科院分区：
文献类型：
--
作者：
Suprin, Melissa;Chow, Allan;Tomlin, Irene
在进行临床试验期间，有效的质量风险管理是确保人体受试者保护和临床试验结果可靠性的基础。质量风险管理支持临床开发项目的有效交付，并最终将治疗交付给患者。因此，风险管理是有效质量管理体系（QMS）的核心要素，如transelerate临床质量管理体系（CQMS）概念框架所述。此外，随着监管机构采用风险管理元素来促进积极主动的质量管理，临床开发中的质量风险管理也在不断发展。本文的目标是为质量风险管理提供一个概念性框架，作为CQMS的一部分。探讨了质量风险管理程序的组成部分，包括适合临床开发的基本要素和质量风险管理方法。
Effective quality risk management is fundamental to ensuring the protection of human subjects and reliability of clinical trial results during the conduct of clinical trials. Quality risk management supports effective delivery of clinical development programs and ultimately delivery of treatments to patients. Thus, risk management is a core element of an effective quality management system (QMS) as described in the TransCelerate Clinical Quality Management System (CQMS) conceptual framework. In addition, the landscape of quality risk management in clinical development evolves as regulatory authorities adopt elements of risk management to promote proactive quality management. This paper's goal is to provide a conceptual framework for quality risk management as part of a CQMS. The components of a quality risk management program are explored including foundational elements and quality risk management methods appropriate for clinical development.