Regulatory Knowledge and Support
The goal of the Regulatory Knowledge and Support Program is to be a 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.
Consultations
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. Email [email protected] to schedule a consultation.
Resources
Contacts
Director of Research Support
Marisabel Davalos, MSEd., CIP
Phone: 305-243-6978
Email: [email protected]