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Risk-Based Monitoring is a clinical trial monitoring technique that satisfies regulatory requirements

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Sharvari Gaikwad
Risk-Based Monitoring is a clinical trial monitoring technique that satisfies regulatory requirements

Risk-based monitoring is a clinical trial monitoring technique that is critical for ensuring patient safety as well as maintaining high data quality. It makes use of a variety of tools and platforms to identify potential problems with trial conduct, safety, data integration, and compliance. Clinical study quality is improved and costs are reduced when risk-based monitoring is used. Regulatory authorities recognise the potential of risk-based monitoring to improve clinical trials at all stages and have published risk-based monitoring guidance documents. According to an article published by the National Center for Biotechnology Information in 2016, the International Conference on Harmonization (ICH) mandated that sponsors develop a risk-based monitoring approach for clinical trials.


Risk-based monitoring concentrates on high-risk areas—both scientifically and operationally – and uses technology and other resources to mitigate these risks. The first step toward successful RBM is risk assessment and the identification of high-risk areas. As a result, it is critical to identify the KRIs (Key Risk Indicators) and implement the appropriate triggers, alerts, and responses. Following the assessment, risk mitigation and risk management strategies are implemented.


The environment has shifted dramatically across the clinical trial horizon. Until recently, the only and most acceptable method of quality control in clinical trials was on-site monitoring. However, the resources required for onsite monitoring are substantial. Even after such an expensive and time-consuming process, the data is not error-free. RBM has improved clinical trials by making them more efficient, safer for patients, and less prone to errors. Following that, we will look at how RBM can be successfully implemented.


In order for critical data to be flagged as potentially dangerous, a sponsor must first identify the expected/acceptable values and parameters. Previous research can be used to help identify and quantify these metrics as high, medium, or low risk.


The mitigation for a given identified risk can change throughout the trial, and the risk categorization does not need to be entered when working with the risk assessment categorization tool for the first time (RACT). High risk data points include any that have an impact on patient safety, as well as the use of trial sites with little or no experience with clinical trials or endpoint data categories.


Read more @ https://medium.com/@sharvaricmi/risk-based-monitoring-is-used-for-financial-accounting-and-enterprise-management-systems-4807ade0b8a3




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Sharvari Gaikwad
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