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# Public Meeting on Clinical Study Quality
- URL: https://www.fdaweb.com/public-meeting-on-clinical-study-quality/
- Published: 2023-11-28T12:00:00.000Z
- Updated: 2026-09-14T14:17:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155872

FDA and the Duke-Margolis Center for Health Policy are holding a hybrid (online/in-person) [public meeting](http://ts may register to attend this hybrid meeting either virtually or in-person by visiting the Duke-Margolis w) 1/31 on “Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches.”

The meeting is intended to discuss with stakeholders the challenges and successes when integrating QbD and RBM into clinical study design and conduct. The meeting objectives are to:

- Encourage QbD principles in study design and conduct, including the development of study protocols and workflow processes
- Identify barriers to QbD and RBM use by sponsors, clinical research organizations, and clinical trial sites
- Inform best practices for utilizing QbD and RBM approaches

For years, FDA says it has encouraged the use of QbD and RBM through many outreach activities, such as [co-hosting a 2019 public workshop](https://healthpolicy.duke.edu/events/improving-implementation-risk-based-monitoring-approaches-clinical-investigations?ref=fdaweb.com) in 2019 on implementing RBM approaches in clinical investigations. FDA has also recently published several guidances on the topics, including [E6(R3) Good Clinical Practice](https://www.fda.gov/media/169090/download?ref=fdaweb.com), [A Risk-Based Approach to Monitoring of Clinical Investigations – Questions and Answers](https://www.fda.gov/media/121479/download?ref=fdaweb.com), and [E8(R1) General Considerations for Clinical Studies](https://www.fda.gov/media/157560/download?ref=fdaweb.com).