Reference cardMonitoring
Which FDA guidance should I quote when a site asks why I am not doing 100 percent SDV?
FDA's guidance "Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring" sets out FDA's thinking on risk-based monitoring of clinical investigations.
Next steps
- Read "Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring" on the FDA website.
From the question: Which FDA guidance should I quote when a site asks why I am not doing 100 percent SDV?