RBQMRisk-Based Quality Management
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RBQM strategy depends on who oversees the monitoring activities, Because "the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor/'the sponsor should perform independent regular Data Quality Assessments (Risk Control).This is more than compliancy checks (i.e.
RBM is one Risk Control among many others in a RBQM strategy: it controls some of the identified risks by mixing on-site and central monitoring activities.
There is also confusing terminology, some of which are used interchangeably in error: RBQM, RBM, Reduced SDV, Key Risk Indicators, Remote Monitoring, Central Monitoring, and Quality by Design.
In summary, RBQM is global, it impacts and involves everyone.