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Clinical Trials Standard Operating Procedure 18 Risk Assessment and MonitoringRisk Assessment and MonitoringVersion1.4Effective date:9 December 2013Author:Claire Differ, QA Manager Approval:Dr Sarah
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Risk assessment and monitoring is the process of identifying, analyzing, and evaluating potential risks to an organization and implementing measures to mitigate or manage those risks.
All organizations, businesses, and individuals who are involved in high-risk activities or industries are required to file risk assessment and monitoring.
Risk assessment and monitoring forms can be filled out online or on paper, and should include information about the nature of the risks, potential impact, and proposed risk management strategies.
The purpose of risk assessment and monitoring is to proactively identify and manage potential risks to prevent loss, harm, or negative impacts to an organization.
Information such as the identification of risks, assessment of likelihood and impact, proposed risk management strategies, and monitoring and review processes must be reported on risk assessment and monitoring.
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