The research priorities of the Cancer Center cut across and align with three main research programs – one of which is the Cancer Control and Population Sciences (CCPS). To assist with the development, implementation and success of CCPS work, the UF Health Cancer Center (UFHCC) has the availability of the CCPS Navigator Team to assist with cancer-relevant research.
In 2019, the UFHCC Clinical Research Office (CRO) established a Cancer Control and Population Science (CCPS) Navigator team to assist investigators with identifying and accessing clinical trial resources and successfully navigating trial activation and data reporting processes specific to National Cancer Institute (NCI) requirements. The primary role of the CCPS Navigator team is to “navigate” investigators and their study teams to resources that support the successful completion of CCPS-related research, particularly with regard to the nuances of cancer-relevant research processes at UF. This includes support for: 1) regulatory and ancillary committee submissions; 2) feasibility assessments to maximize accrual opportunities in the clinics and community; 3) collection and reporting of required enrollment data; and 4) connection with available resources within the UFHCC and general UF research community.
How do I get cancer-relevant research approved at UF?
Most cancer-relevant research at UF requires a two-step review process BEFORE submission to the IRB. This is required by the NCI and focuses on ensuring study feasibility, methodology, scientific merit and meeting reporting requirements.
- Step 1: Obtain endorsement by the appropriate UFHCC Disease Site Group (DSG). To start this process, contact UFHCC-CCPSNavigator@cancer.ufl.edu with your request. Some exceptions to this first step may be granted, if consistent with institutional policies.
- Step 2: Obtain Scientific Review and Monitoring Committee (SRMC) approval. The CCPS Navigator team (UFHCC-CCPSNavigator@cancer.ufl.edu) can help facilitate the detailed application process after DSG endorsement (if applicable).
NOTE: Consistent with UF Policies, SRMC review and approval is required of all cancer-relevant research PRIOR TO IRB APPROVAL.
Step 3: UF IRB submission. Whether IRB-01 (Health Sciences Campus) or IRB-02 (Main Campus), the submission process uses myIRB. More information about registration with myIRB and required trainings can be found on the UF IRB webpage (https://irb.ufl.edu/). The CCPS Navigator team (UFHCC-CCPSNavigator@cancer.ufl.edu) can assist Cancer Center members with IRB submission.
Step 4: Study Activation. Once approved by the IRB and your study is ready for activation, please contact the CCPS Navigator Team (UFHCC-CCPSNavigator@cancer.ufl.edu) so we can record your study as “Open to Accrual”. We can facilitate activating the study in OnCore (UF’s Clinical Trials Management System) which makes it immediately visible on the UFHCC NaviGATOR app/webpage (http://oncore.cancer.ufl.edu/sip-mobile/).
To improve efficiency in communicating with the Navigator team, you may also choose to add one of our staff members to your study in myIRB as a “guest” – consult the navigator team to know which staff member this should be. See screenshot, below, for how to use the Guest List option:
Once my study is approved, what data do I have to report to the UFHCC for cancer-relevant research at UF?
All investigators conducting cancer-relevant research at UF are responsible for providing the UFHCC with status updates and select data from your research, consistent with NCI accreditation requirements, even if your study is not directly funded by the NCI. In general, the status of your research, including accruals, must be maintained through OnCore, even if you are using another data collection system (e.g., REDcap). Fortunately, the CCPS Navigator Team can support you in meeting these institutional requirements. More information about these data reporting requirements can be found here: Data Requirements for Cancer Center Reporting
For interventional clinical trials, our CCPS Navigator Team (UFHCC-CCPSNavigator@cancer.ufl.edu) must have access to subject level accrual information. Direct read only access to your accrual information is preferred to streamline reporting as new subject enrollments must be entered into OnCore in real time. The team can guide you through the reporting process and answer any questions you may have about what information is required.
For non-interventional or observational studies, direct access to accrual information is preferred. If direct access cannot be accommodated, you will be contacted by a Navigator or SRMC team member around the end of each quarter (April, July, October, and January) for updated subject accrual information. If you are contacted by a team member, please respond as quickly as possible.
Finally, if the status of your protocol changes (e.g., a temporary hold of accrual, closing to accrual, or closing with the IRB) please contact the CCPS Navigator Team to let us know so we can update the database accordingly for your team.
For more information about the research resources available to you across campus and other helpful contacts, please see below.
Study Development Resources
- Protocol Template Document (now also found in myIRB!)
- SRMC Intake Form (HSC VPN required)
- Disease Site Group (DSG)
- Biostatistics & Quantitative Sciences (BQS)
- UF Office of Clinical Research (OCR)
- OneFlorida Research Consortium
- UFHCC Community Outreach and Engagement Office
- CTSI Recruitment Center
- Human Subject Payments (subject compensation)
For more information or to access these complimentary UFHCC CCPS Navigator Team Services, please contact