Ashok Ghone Risk Based Approach To Clinical Trial Management

Author: Ashok Ghone

Risk management principles are widely used in other industry such as finance, aviation and insurance. The concept of risk management is not totally new in clinical trial management, however the industry has started formally and systematically looking into it after the release of the FDA guidance document and EMEA reflection paper in 2012. With release of ICH E6 R (2) in 2016, the industry has started shifting from just risk based monitoring to an overall risk based approach to quality management and oversight. The basic concept behind risk-based approach is proactively identifying potential risks to the critical data, processes and managing them effectively before getting into issues without affecting quality and integrity of the data. It is important to be more proactive than reactive to ensure quality, patient safety and efficiencies in clinical trials. The key to a successful implementation of these new approaches is to change the mindset and practice of the traditional way of designing, planning and executing of clinical trials and take up a more proactive, risk based quality management approach.

The content, tools and templates presented in this book will be helpful to the readers to understand the concept of risk based approach to clinical trial management. This book is useful to the readers involved in clinical development, clinical trial operations, clinical trial management, clinical quality managements and also to clinical research students to get better understanding of risk based quality management, risk based monitoring, centralized monitoring and oversight. However, one needs to take a study specific approach based on the study requirements to implement risk based quality management or risk based monitoring to bring better results.

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