About Us » Overview
In December, 2005, the Clinical Trials Compliance Office was created to develop, coordinate, communicate, plan, implement, monitor, and report fiscal compliance policies, standards and processes for clinical trials research. We are charged with ensuring that the University of Florida, College of Medicine complies with all federal and state regulations that concern clinical trials.
The fiscal responsibility of an Academic Health Center has far reaching effects in conducting clinical trials. Our actions can affect our patients, our investigators and our institution, the University of Florida. This website was designed to explain, assist, and challenge us all to conduct our clinical trials while meeting the highest ethical standard and follow all the applicable federal and state laws and policies that govern how we conduct clinical trials.
Mission Statement
The Clinical Trials Compliance Office provides fiscal training, education and support to our investigators and their designated staff to facilitate the successful conduct of clinical trials in the College of Medicine. Our mission is to ensure clinical trials are conducted in a fiscally compliant, lawful and ethical way that benefits our study participants, faculty, employees and institution. Fiscal compliance is a process that begins with the development of the study protocol, budget and contract and continues until the study closes and all clinical trial charges are settled. Further, our mission is to support clinical trial operations that ensure all payment sources are clearly identified and properly billed according to all federal and state regulations.
back to top Code of Conduct
University of Florida policy requires all clinical trial research conducted at the University of Florida, College of Medicine to be in compliance with applicable state and federal regulations. All Principal Investigators and their designees will provide necessary information to appropriate hospital, professional and other outside service personnel that are required to support the execution of the study (Service Providers) to ensure proper billing procedures are followed for all concurrent payors. These concurrent payors may include the sponsor (contracting agency, granting agency), study participants and their 3rd party payors, including Medicare and other government payors.
Code of Conduct for the University of Florida
Physicians are required to read and sign the Code of Conduct above before ordering any patient or study participant services. Contact the Office of Compliance for Physician Billing for further assistance.
Clinical Trials Compliance Responsibilities
All of the following compliance responsibilities relate to clinical trial and other types of clinical research fiscal activities that may involve billing for medical services:
- Create and incorporate policies and standards to guide UF employees and/or its agents with regard to clinical trial fiscal activities.
- Facilitate clinical trials research compliance initiatives throughout UF and UF-related entities.
- Provide education and training opportunities for investigators, clinical coordinators, and other research-related staff concerning clinical trial research-related statutory and regulatory requirements and UF policies.
- Provide a mechanism for employees to raise questions and to receive appropriate guidance concerning clinical trial research-related statutory and regulatory requirements.
- Regularly review and monitor clinical trial research activity by UF employees and/or UF agents to assess compliance and to identify potential noncompliance.
- Develop and maintain a process for employees to report instances of possible noncompliance and for such reports to be fully and independently reviewed.
- Develop a process for formulating and recommending corrective action plans to address any instances of noncompliance with UF clinical trial research-related policies and with federal and state laws and regulations related to research.
- The Clinical Trials Compliance Office employees have full authority to review all research-related documents, financial records, contracts, and other information necessary to ensure compliance with regulatory requirements pertaining to research.