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# Risk-Based Investigation Guidance
- URL: https://www.fdaweb.com/risk-based-investigation-guidance/
- Published: 2019-03-14T12:00:00.000Z
- Updated: 2026-09-15T01:12:56.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5143603

FDA has issued a draft guidance, *A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers*, with guidance on risk-based approaches to monitoring investigational studies of human drugs and biological products, medical devices, and combinations. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM633316.pdf?ref=fdaweb.com) has recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. It expands on an 8/2013 guidance by providing additional guidance to facilitate sponsors’ implementation of risk-based monitoring.

“FDA believes risk-based monitoring is an important tool to allow sponsors to identify and address issues during the conduct of clinical investigations,” the guidance says. “FDA’s experience since finalizing the risk-based management guidance in 2013 suggests that additional guidance would be beneficial regarding FDA’s recommendations for planning a monitoring approach, developing the content of monitoring plans, and addressing and communicating monitoring results.”