Effective implementation of risk-based monitoring should help maximize the quality of a clinical investigation. The U.S. Food and Drug Administration (FDA) has released guidance for the industry regarding risk-based approaches to monitoring clinical investigations of human drug and biological products, medical devices, and combination products. The guidance, titled, “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers,” provides recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results.
After some background, the guidance provides answers to specific questions in three different areas:
- Monitoring Approach
- Monitoring Plan Content
- Follow-up and Communication of Monitoring Results
Visit the FDA guidance page to download the complete document and for instructions on how to submit a formal comment.
