The Office of Clinical Research Compliance provides world class quality assurance and research compliance support to our research community and our collaborators. We cultivate collegial and collaborative relationships with our researchers and their staff to ensure patient safety and financial integrity while remaining compliant with local and federal regulations. With transparency at the forefront, we work closely with our researchers to review the intricate details of the research studies to ensure protocol alignment and streamline any processes and workflows as needed.
The Office of Research Compliance supports the Tampa General Hospital research community through the management of Conflicts of Interest (COI), the Quality Review Program (QRP) the Research Billing Financial Review Program (RBFR) and the investigation of scientific misconduct.
Meet Our Team
Lynn E. Smith, JD, CHRC
Director, Research Compliance Officer
Tampa General Hospital
813-660-6257 - Office
lynnsmith@tgh.org
Angela Brinkley, MS, LATG, CPIA
Clinical Research Quality Assurance, Program Manager
Tampa General Hospital
813-660-6764 - Office
abrinkley@tgh.org
Dustin Moore, MSA
Sr. Research Compliance Specialist
Tampa General Hospital
813-844-4818 – Office
dmoore@tgh.org
Amy Holbert, MA
Research Compliance Quality Assurance Monitor
Tampa General Hospital
813-844-5058 – Office
aholbert@tgh.org
The Quality Review Program (QRP)
The Quality Review Program (QRP) provides world class quality assurance and research compliance support to our research community and our collaborators. We cultivate collegial and collaborative relationships with our researchers and their staff to ensure patient safety while remaining compliant with local and federal regulations and offering guidance to researchers in alignment with best practices and compliance. With transparency at the forefront, we work closely with our researchers to review the intricate details of the research studies to ensure protocol alignment and streamline any processes and workflows as needed.
The reviews conducted by the Quality Review Program staff will assist in the protection of participants enrolled in a research protocol and will provide an internal mechanism for quality assurance, quality improvement, and education related to the conduct of clinical research protocols. The results of reviews will serve to educate, achieve best practices and verify participant safety and study data. Consider the Quality Review Program visit as a wellness plan for your research!
The Quality Assurance Monitors will work with the researcher and their staff to create new processes or streamline the current workflow to ensure compliance. Any investigator or study team member may request the assistance of the Quality Review Program at any time.
Consider the QRP visit as a wellness plan for your research!
V95 In-Service Certificate
Brown Bag Licensed V95A
The Brown Bag is held informal educational presentation offered virtually to our research community and behind the 2nd Thursday of each month from 12 pm - 1 pm. This platform supports our research team members by educating them on research-related topics and quality improvements noted during QRP visits. We also welcome topic suggestions from our team members, so feel free to contact us via the Brown Bag email: BrownBag@tgh.org.
Click here to access the meeting
Research Billing and Financial Review Program (RBFR)
The purpose of the RBFR plan is to ensure Financial and billing compliance with federal and state regulations and laws, institutional policies, and Institutional Review Board (IRB) requirements. Reviewing and Working with all teams involved in Research Billing from Regulatory, pre-study operations, mid-study accrual, billing the Research charges, and managing Hospital claims, including assisting denials teams. RBFR program will be an internal mechanism for Financial/Billing quality assurance, quality improvement, and education related to the fiscal relationship to research protocols. This will assist protecting the Hospital and providers from the Harsh Penalties of Governmental noncompliance from the complexities of Research Billing.
Any investigator or study team member may request the assistance of the Research Billing and Financial Review Program at any time.
Reporting Concerns
For Research Compliance inquiries or reporting concerns please contact us at researchcompliance@tgh.org.