In August 2013, the FDA finalized the Guideline: Oversight of Clinical Investigations —A Risk-Based Approach to Monitoring. This guidance – in combination with others – is representative of a new era in clinical trials, sometimes termed “a clinical quality revolution.” This course presents a succinct review of the differences between the draft and the final guidance, an example of an industry impact analysis, and finally a gap analysis tool to help guide decision-making and implementation planning.
At the conclusion of this 90-minute session, participants will be able to:
- Identify updates to the FDA Risk-based Monitoring (RBM) Guidance, and act on them
- Recognize where risk-based decision making fits into your clinical quality system
- Apply critical industry impact analysis of RBM and clinical site management operations
- Utilize gap analysis to initiate or update a RBM approach within clinical quality systems
- Recognize and adapt various approaches to risk assessment and project scoring for RBM approaches to study and site management
- Identify components to include in risk assessment practices – from site monitoring to personnel performance assessments