The Clinical Scientific Review Committee (CSRC) at the OSUCCC – James plays a vital role in protocol review and monitoring to ensure that clinical trials are scientifically sound and that approved trials maintain patient accrual goals and scientific progress.
The CSRC operates in collaboration with the OSUCCC – James Clinical Trials Office (CTO) while maintaining separate responsibilities and reporting. The CSRC meets twice a month to review all proposed cancer-related protocols conducted at the OSUCCC, including the James Cancer Hospital and Solove Research Institute, Columbus Nationwide Children's Hospital, Cincinnati Children's Hospital and The Ohio State University Wexner Medical Center. All cancer-related research is required to have prior CSRC approval before the protocol can be submitted to one of Ohio State’s Institutional Review Boards (IRB).
Quality Assurance (QA) audits are performed by the Office for Protocol Compliance. Monitoring for accrual is performed by the CSRC. Serious adverse events (SAEs) are reported by CTO staff to the Cancer IRB, and the routine monitoring of SAEs is performed by the Data & Safety Monitoring Committee.
The mission of the CSRC is to evaluate the scientific validity of all proposed OSUCCC – James clinical trials and to monitor the scientific progress and accrual status of open trials.
The specific aims of the CSRC are:
- To establish and maintain a review committee of sufficient size and breadth of expertise to conduct a critical and fair scientific review of institutional cancer-related research protocols involving human subjects
- To conduct a thorough scientific review of all non-peer-reviewed, cancer-related clinical protocols conducted at the OSUCCC – James based on specific, pre-determined review criteria
- To oversee the prioritization of competing protocols, thus ensuring optimal use of the OSUCCC – James’ clinical resources for the achievement of its scientific goals
- To establish clear criteria for determining whether ongoing clinical trials are making sufficient scientific progress, including the attainment of adequate patient accrual rates
- To monitor all cancer-related research protocols based on the criteria established by the CSRC and to terminate protocols that do not meet these expectations