Regulatory Knowledge and Support

Regulatory Knowledge and Support is 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. It provides guidance early in the planning of pre-clinical studies, clinical protocols, regulatory agency interface and filings, and clinical trials support throughout study implementation.


Consultations can be provided 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.