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# Workshop on Study Risk-Based Monitoring
- URL: https://www.fdaweb.com/workshop-on-study-risk-based-monitoring/
- Published: 2019-05-30T12:00:00.000Z
- Updated: 2026-09-15T01:29:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144218

FDA has announced a 7/17 [public workshop](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-11411.pdf?ref=fdaweb.com) entitled “Improving the Implementation of Risk-Based Monitoring (RBM) Approaches of Clinical Investigations.” The workshop is intended to capture stakeholder experiences with risk-based approaches to monitoring of clinical investigations and gather stakeholder input on opportunities to further implement risk-based approaches to monitoring.

The workshop is based on recommendations in a 3/15 [draft guidance](https://www.fda.gov/media/121479/download?ref=fdaweb.com) entitled “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.” FDA says that traditionally sponsors and research organizations have depended upon on-site monitoring and 100% source data verification for each clinical site, an approach that is resource intensive and may contribute to increased clinical trial costs. “Adoption of RBM could lead to improvements to human subject protections, data integrity, and the efficiency of clinical investigations,” an FDA notice says. “Data suggest that RBM has not yet been widely implemented. Therefore, FDA is seeking additional feedback from stakeholders on the challenges, barriers, and enablers that might be impacting the adoption of RBM.”