Regulatory Management provides administrative support to Sylvester investigators and research personnel. Our services include:
- Coordination of initial and follow-up protocol document submissions to University and external regulatory bodies
- Assistance with preparation of informed consent documents
- Assistance with preparation of Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications to the Food and Drug Administration (FDA)
- Maintenance of regulatory documents in accordance with federal requirements
- Regulatory compliance training of Sylvester investigators and research personnel
Our office works closely with a number of University units to maintain compliance with federal and state regulatory requirements, these include the Human Subjects Research Office, Office of Research Compliance Assessment, and the University’s ancillary review committees. For more information on how this office may assist you, please contact Patricia Thomas at 305-243-5293.