The Scientific Review and Monitoring Committee (SRMC) is a joint multidisciplinary committee comprising researchers from across the UF campus. The committee’s mission is to enhance the quality of cancer research by providing scientific oversight for cancer-relevant research conducted on our campuses.
The SRMC reviews all studies of cancer or that are specific to patients with cancer and are conducted by faculty, staff or students at the UF Health Gainesville campus and the UF Health Proton Therapy Institute. All interventional studies must be reviewed and approved by the appropriate Disease Site Group (DSG) or Research Program prior to SRMC review.
The SRMC has the authority to approve, require changes or disapprove studies. Interventional trials approved by the SRMC will be reviewed while open to accrual to determine whether a study demonstrates continued scientific merit and meets satisfactory progress toward achievement of study endpoints. In addition, the SRMC will review all major protocol amendments to interventional trials.
During the initial submission and subsequent reviews, the SRMC may recommend amendments to, or termination of, a protocol. Such reasons include the development of therapy that is superior to that proposed in the protocol or a change in the standard of care that is no longer reflected in the protocol, poor accrual or other scientific or administrative reasons. These recommendations should be inclusive of recommendations and oversight from the Data Integrity and Safety Committee (DISC).
The SRMC will ensure effective allocation of Cancer Center resources to support research protocols by evaluating each protocol for:
- Scientific merit
- Risk/benefit ratio
- Biostatistical soundness
- Resource utilization
A Protocol Review and Management System (PRMS), as defined by the Cancer Center Support Grant (CCSG), must be used by a cancer center to receive National Cancer Institute (NCI) designation.
NCI Guidelines for a PRMS include the following:
- A qualified committee of and adequate size and with the breadth of expertise necessary to conduct a critical and fair scientific review of all institutional clinical cancer protocols;
- A committee with sufficient authority and processes for initiating, monitoring and terminating all cancer clinical research protocols in the institution(s) comprising the Center;
- Clear criteria and processes for scientific review, taking into account the rationale and study design, potential duplication of studies elsewhere, adequacy of biostatistical input, and feasibility for completion within a reasonable time;
- Appropriate processes for ensuring prioritization of competing protocols from all sources and optimal use of the Center’s scientific resources;
- Robust criteria for monitoring trials to ensure they are making sufficient scientific progress; and
- Adequate and appropriate criteria and process for terminating trials that do not meet scientific goals (trials involving rare diseases are excluded).
