The future of monitoring in clinical research – a holistic approach: Linking risk-based monitoring with quality management principles

Eva B. Ansmann; Arthur Hecht; Doris K. Henn; Sabine Leptien; Hans Günther Stelzer

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The future of monitoring in clinical research – a holistic approach: Linking risk-based monitoring with quality management principles

机译：临床研究中监测的未来–整体方法：将基于风险的监测与质量管理原则联系起来

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Since several years risk-based monitoring is the new “magic bullet” for improvement in clinical research. Lots of authors in clinical research ranging from industry and academia to authorities are keen on demonstrating better monitoring-efficiency by reducing monitoring visits, monitoring time on site, monitoring costs and so on, always arguing with the use of risk-based monitoring principles. Mostly forgotten is the fact, that the use of risk-based monitoring is only adequate if all mandatory prerequisites at site and for the monitor and the sponsor are fulfilled. Based on the relevant chapter in ICH GCP (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use – Good Clinical Practice) this publication takes a holistic approach by identifying and describing the requirements for future monitoring and the use of risk-based monitoring. As the authors are operational managers as well as QA (Quality Assurance) experts, both aspects are represented to come up with efficient and qualitative ways of future monitoring according to ICH GCP.

机译：多年来，基于风险的监视已成为改善临床研究的新“灵丹妙药”。从行业，学术界到权威机构，许多临床研究的作者都渴望通过减少监视访问，现场监视时间，监视成本等方式来展示更好的监视效率，并一直争论基于风险的监视原则的使用。最被人们遗忘的事实是，基于风险的监控仅在满足现场以及监控者和发起者的所有强制性前提条件时才足够。该出版物以ICH GCP（人类使用药品注册的技术要求国际协调会议-良好临床实践）的相关章节为基础，通过识别和描述未来监控和基于风险的使用的要求，采用了整体方法监控。由于作者既是运营经理，又是QA（质量保证）专家，因此根据ICH GCP，这两个方面的代表都提出了有效和定性的未来监控方法。

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《German Medical Science》 |2013年第1期|共页
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Eva B. Ansmann; Arthur Hecht; Doris K. Henn; Sabine Leptien; Hans Günther Stelzer;
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中图分类医药、卫生;
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The future of monitoring in clinical research – a holistic approach: Linking risk-based monitoring with quality management principles

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