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SCCR’s Quality and Compliance team calls attention to a document recently issued by the FDA:  draft guidance on risk-based monitoring.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The FDA distributed the guidance document for comment purposes only.