As a National Cancer Institute (NCI) designated Comprehensive Cancer Center, the NCI requires that each cancer center have a protocol review and monitoring system to assess scientific merit and feasibility of all protocols studying subjects diagnosed with, or at risk for, cancer conducted at the cancer center and to monitor for accrual and scientific relevance.
The protocol review and monitoring system of the cancer center provides a mechanism for ensuring internal oversight of the scientific and research aspects of cancer clinical trials and for assuring that the cancer center's clinical resources are engaged in the most optimal way. The protocol review and monitoring system is intended to cover clinical research activity meeting the NCI definition of a clinical trial, as defined in the data and safety monitoring plan within the clinical protocol and data management of this application.
The disease teams and scientific review committee together comprise cancer center’s two-stage protocol review and monitoring system. All cancer-related, hypothesis-driven clinical research studies must receive protocol review and monitoring system approval prior to activation. The disease team must endorse the trial prior to submission to scientific review committee.
When the disease team approves the study to move forward through the start-up process and is then presented to the scientific review committee which provides internal peer-review and approval of new treatment and prevention research trials prior to submission to the Institutional Review Board, which focuses on the protection of human subjects. scientific review committee provides essential review elements for scientific merit, prioritization, resource allocation and accrual monitoring.
The protocol accrual monitoring committee, a subcommittee of the scientific review committee, is charged with monitoring accruals and sending reminders to investigators prior to full-board scientific review committee intervention.
Additionally, investigator-initiated interventional clinical research protocols require data and safety monitoring oversight through the cancer center’s data and safety monitoring board.
The office of Clinical Research is responsible for:
- Protocol development services
- Regulatory oversight
- Budget development and approval, contract management
- Financial oversight
- Clinical research billing management
- Protocol and data management
- Patient care coordination
- Clinical Trial Monitoring
- Quality assurance
- Specimen processing
.jpg)
