> ## Content Index
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# Guide on Clinical Trial Monitoring
- URL: https://www.fdaweb.com/guide-on-clinical-trial-monitoring/
- Published: 2023-04-12T12:00:00.000Z
- Updated: 2026-09-14T18:25:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154192

*Federal Register* notice: FDA is making available a final guidance entitled “A Risk- Based Approach to Monitoring of Clinical Investigations — Questions and Answers.” The document provides risk-based approaches for monitoring drug, biologic and medical device investigational studies. It also contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-04-12/pdf/2023-07687.pdf?ref=fdaweb.com).