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# Draft Guide on Clinical Trial Sponsor Monitoring
- URL: https://www.fdaweb.com/draft-guide-on-clinical-trial-sponsor-monitoring/
- Published: 2019-03-15T12:00:00.000Z
- Updated: 2026-09-15T01:13:10.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143620

*Federal Register* notice: FDA has made available a draft guidance entitled “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.” The document provides information to sponsors on risk-based approaches to monitoring of investigational studies of human drug and biological products, medical devices, and product combinations. It also expands on an 8/2013 guidance for industry entitled “Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring.” To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-03-15/pdf/2019-04814.pdf?ref=fdaweb.com).