Miami CTSI

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Regulatory Knowledge and Support

The goal of the Regulatory Knowledge and Support Program is to be a centralized resource for assuring consistent standards in the protection of human subjects and compliance with University of Miami (UM) policies, and state and federal regulations. The program provides leadership, expertise, and guidance early in the planning of pre-clinical studies, clinical protocols, regulatory agency interface and filings, and clinical trials support throughout study implementation.


The program can provide free consultations on how to improve the quality of regulatory adherence in clinical research protocols and assure participant safety through data and safety monitoring planning and implementation, particularly at the time of study development.


Tools & Templates

Human Subject Regulation Decision Charts
Adapted from the U.S. Department of Health & Human Services (HHS)


Program Director
Jonelle Wright, Ph.D.
Associate Director, Miami Clinical & Translational Science Institute (CTSI)
Associate Dean, Research & Regulatory Quality Improvement
Research Associate Professor, Department of Surgery

Director of Research Support
Marisabel Davalos, MSEd., CIP
Phone: 305-243-6978

Director, Regulatory Support
Sorelly Gil, MD, MBA

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