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.
Conflict of Interest
The Office of Research Compliance monitors the COI disclosures of our research investigators and study teams. Investigators are asked during the protocol submission process about any potential conflicts of interest they may have with the sponsor(s) of the research protocol. When a disclosure is made, we work with the investigator or study team member to determine whether the interest will require management. We use a template COI management plan to create a plan that is appropriate for the type and the amount of interest.
For more information about Investigator and study team member COI, please review our policy OCR-255: Investigator Conflicts of Interest for Research.
The Quality Review Program (QRP)
The 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 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 QRP at any time.
The reviews conducted by the QRP 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 QRP visit as a wellness plan for your research!
V95 In-Service Certificate
Download the V95 In-Service Certificate
Brown Bag Licensed V95A
The Brown Bag is an informal educational presentation offered virtually to our research community and held 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.
Scientific Misconduct
The Office of Research Compliance maintains a policy and a process to deal with any allegations of Scientific Misconduct (also referred to as Research Misconduct). Scientific Misconduct is limited to the following three behaviors: (1) fabrication (e.g., making up data or results), (2) falsification (e.g., manipulating research materials, equipment, or processes, or changing or omitting data or results), and (3) plagiarism (e.g., using another person’s ideas, processes, results or words without giving appropriate credit).
Please contact the Office of Research Compliance if you are aware of any of these activities. We are prepared to assess allegations, including an initial inquiry as well as a formal investigation, should that be warranted. For more information on Scientific Misconduct, please review our policy OCR-231: Handling Potential Research 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