Quality and Compliance Corner: Guidance on Risk-Based Monitoring (RBM)
SCCR’s Quality and Compliance team calls attention to a document recently issued by the FDA: draft guidance on risk-based monitoring.
Through a series of questions and answers, the document is intended to assist research sponsors with the development of RBM plans.
In the draft, the FDA shares its perspective on:
· Documenting risk assessment methodologies and activities
· Risks that should be monitored
· Factors to consider in determining the timing, types, frequency, and extent of monitoring activities
· Centralized, real-time monitoring
· Elements to be included in a monitoring plan
· Communication of monitoring results
The FDA distributed the guidance document for comment purposes only.