The research priorities of the Cancer Center align with four main research programs, one of which is the Cancer Control and Population Sciences (CCPS) program. To assist with the development, implementation, and success of CCPS work, the UF Health Cancer Center has the CCPS Navigator Team to assist with cancer-relevant research.
In 2019, the UF Health Cancer Center Clinical Research Office (CRO) established a Cancer Control and Population Science (CCPS) Navigator Team to assist investigators with trial activation and data reporting requirements.
This includes support for:
- Regulatory and ancillary committee submissions
- Feasibility assessments to maximize accrual opportunities in the clinics and community
- Collection and reporting of required enrollment data
- Connection with available resources within the UF Health Cancer Center and general UF research community
Steps to opening a cancer-relevant study at UF
Most cancer-relevant research at UF requires a two-step review process BEFORE submission to the IRB. This is required by the National Cancer Institute (NCI) and focuses on ensuring study feasibility, methodology, and scientific merit and meeting reporting requirements.
STEP 1: Obtain endorsement by the appropriate Disease Site Group (DSG). 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 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: IRB submission. Local IRB-01 (Health Sciences Campus) or IRB-02 (Main Campus) submission uses myIRB. More information about registration with myIRB and required trainings can be found on the UF IRB webpage. The CCPS Navigator team can assist Cancer Center members with IRB submission.
STEP 4: Study activation. Once approved by the IRB and your study is ready for activation, notify the CCPS Navigator Team to record your study as “Open to Accrual.” This will be captured within OnCore (UF’s Clinical Trials Management System), which makes the study visible on the UF Health Cancer Center NaviGATOR app/webpage and begins SRMC tracking for continuation reviews.
To enhance communication efficiency, you may also add a CCPS team member to your study in myIRB as a “guest” for read-only view.
Once IRB approved, what data must be reported to the UF Health Cancer Center for cancer-relevant research at UF?
All investigators conducting cancer-relevant research at UF are responsible for providing the UF Health Cancer Center with status updates and select data related to subject accruals, consistent with NCI accreditation requirements, even if your study is not directly funded by the NCI. The status of your research, including accruals, must be maintained through OnCore, even if you are using another data collection system (e.g., REDcap). More information about these data reporting requirements can be found in the Data Requirements for Cancer Center Reporting
Accrual Updates
- Interventional clinical trials will be required to provide subject level accrual information.
- Non-interventional or observational studies often will have a shortened, or summary-accrual, option offered.
*It is requested that direct access to study data capture systems like RedCap or myIRB systems be provided to assist with review and capture of accrual updates within OnCore.
Deadlines
| Study type | Required accrual reporting timeframe | accrual reporting type | Quarterly oncore reporting deadlines |
|---|---|---|---|
| Interventional | 1 business day | Patient level | April, July, October, January |
| Non-interventional or observational | Every 30 days | Summary accrual | April, July, October, January |
To streamline data reporting, access to REDCap projects or other project management software may be given to the CCPS Navigator (UFHCC-CCPSNaviGator@cancer.ufl.edu).
Accrual Reporting Tools
Study Development Resources
- Protocol Template Document (now also found in myIRB!)
- SRMC Intake Form (HSC VPN required)
- Disease Site Group (DSG)
- Biostatistics & Computational Biology (BCB-SR)
- UF Office of Clinical Research (OCR)
- OnCore
For more information or to access these complimentary UFHCC CCPS Navigator Team Services, please contact
UFHCC-CCPSNaviGator@cancer.ufl.edu.
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