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Overview

Overview

The University of Florida’s Health Science Center, with the College of Dentistry is committed to developing and expanding clinical research involving patients and other participants. The intent of our clinical research is to explore the effectiveness and safety of medication, devices, diagnostic products, and treatment regimens that can lead to improved oral health care.

The College’s clinical research endeavors encompass areas such as patient care, disease prevention, oral/microbiology, biomaterials, and immunology. We continue to focus on identifying service areas that provide resources to clinical and translational research needs of our community.

NIH Definition of Clinical and/or Human Subject Research – Determining the type of clinical research being proposed or conducted can be complex. The National Institutes of Health website provides a detailed definition and categorization for clinical studies. These definitions are commonly adopted by the University.

Dental Clinical Research Unit (DCRU) The DCRU provides space and resources for dental investigators and other collaborators. Services include assistance with in vitro studies, pharmacology, microbiology, diagnostic methodology and data collection/management. Our DCRU is staffed with study coordinators and dental assistants that will provide expertise in clinical study development and implementation. Located on the first floor of the dental school, the DCRU has multiple operatories, a lab and a conference area.

In order to track compliance, the College requires that all sponsored and resident clinical research is vetted by the DCRU staff. The staff ensures all required documents are accurate, and confirms that the principal investigator has access to the necessary resources to complete the study. The College also requires that clinical research project involving patient care are tracked in the AxiUm clinic management system. In addition to meeting compliance requirements, research projects established in AxiUm give a research team the ability to collect data involving participants and treatments.

Flow chart for AxiUm and clinical research studies: http://research.dental.ufl.edu/files/2012/10/axium-chart.pdf

UFCD Sponsor Billing Grid http://research.dental.ufl.edu/office-of-research/clinical-research/ufcd-office-of-research-clinical-studies

HSC Research Administration and Compliance The Health Science Center’s Office of Research Administration and Compliance (RAC) has oversight for clinical research studies performed on behalf of the University of Florida. The RAC office will review all clinical studies at the proposal stage, and then perform a compliance audit once the study is closed. The staff in the DCRU can assist investigators with RAC document requirements. RAC Process Flow chart.
UF Clinical and Translational Science Institute (CTSI) “The UF CTSI develops research support strategy and executes that strategy to improve the clinical and translational science environment of the University of Florida. The CTSI supports the development of clinical, laboratory and population-based science. The CTSI supports researchers, trainees and community members in their efforts to accelerate discoveries toward better health.” The CTSI website reflects the many resources available to faculty, staff and students conducting clinical research.

Find a research study For individuals interested in finding or participating in a research study, the CTSI provides a searchable database with contact information. The CTSI’s Study Connect site provides a resource for researchers that need assistance with recruitment.

ClinicalTrials.gov “ClinicalTrials.gov is a registry and results database of publically and privately supported studies of human participants conducted around the world.” Most human research studies conducted at UF are required to register with ClinicalTrials.gov. For more information contact the RAC office.

Useful Links and Resources for Clinical Research

College of Dentistry, Dental Clinical Research Unit (DCRU)
UF Health Science Center Research and Compliance (RAC)
UF Clinical and Translational Science Institute (CTSI)
CTSI Services
CTSI Study Registry
UF Institutional Review Board
UF Office of Research, Clinical Trials
ClinicalTrials.gov