For UF Researchers
What is the mission of the Clinical Trials Office?
The mission of the Clinical Trials Office (CTO) is to help deliver new and promising cancer treatments in order to improve the lives of the patients at the UF Health Cancer Center. The CTO provides support to UF Health Cancer Center clinical investigators for the development and implementation of cancer clinical trials. The primary goal of the CTO is to facilitate the conduct of high-quality clinical research while adhering to the highest ethical standards and maintaining compliance with all governing bodies.
What services does the Clinical Trials Office provide?
Clinical Trials Office provides the following services to the clinical investigators of the UF Health Cancer Center:
- Protocol and consent authoring
- Protocol feasibility assessments and budget development
- Regulatory Management
- Submissions to Institutional Review Boards (IRBs)
- Submissions to FDA
- Submissions to study sponsors
- Clinical Trial Coordination
- Patient education
- Patient recruitment
- Study visit coordination
- Data management and monitoring
- Clinicaltrials.gov management
- Research lab processing
- Financial Management
- Budget development and contract negotiations
- Study invoicing and payments for services
- Billing Compliance program management
- Management of UF Health Cancer Center committees
- Management of the OnCore® clinical trials management system (CTMS) software
- Clinical Research Management (CRM)
- Subject Management
- Case Report Form Data Management
- BioSpecimen Management (BSM)
- Unified Registries Management (URM)
- Clinical Research Management (CRM)
- Monitoring and Maintenance of the NCI and other Cooperative Group Memberships
- Blood and Marrow Transplant Clinical Trials Network (BMT CTN)
- Children’s Oncology Group (COG)
- Cancer Trials Support Unit (CTSU)
- Eastern Cooperative Oncology Group (ECOG)
- NRG Oncology Group
- Southwest Oncology Group (SWOG)
Does the Clinical Trials Office have any new services it anticipates adding soon?
The Clinical Trials Office plans to provide clinical trial support for outside institutions with affiliations through the UF Academic Health Center.
- Affiliate sites of the UF Health Cancer Center NRG Oncology Group membership include:
- North Florida South Georgia VA Hospital (Gainesville, FL)
- Tallahassee Memorial Cancer Center (Tallahassee, FL)
- UF Health Proton Therapy Institute (Jacksonville, FL)
The CTO is the enterprise-wide license holder for OnCore®, a cancer-centric clinical trials management system (CTMS). This system also has the functionality to support clinical trials management for many diseases outside of the cancer focus.
How should you contact the Clinical Trials Office to engage its services in a project or ask advice?
For information related to existing active trials please contact 352.273.8675. This can be utilized by physicians, their delegates, and even patients.
For information related to acquiring CTO services for a future clinical trial, please contact Brian Sevier, associate director at email@example.com or 352.273.8280.
This core is available to individuals who are Cancer Center members. In order to become a member of the UF Health Cancer Center, please visit the membership policy and application site. For further questions about membership with the UFHCC, please contact Wendy Malorzo or call 352.273.8294.
How can you provide feedback on the Clinical Trials Office?
Please contact Brian Sevier, associate director, at firstname.lastname@example.org or 352.273.8280 for feedback, questions, or concerns related to the administration of the UF Health Cancer Center Clinical Trials Office.