Background and Mission
What is the SRMC?
A Protocol Review and Management System (PRMS), as defined by the Cancer Center Support Grant (CCSG), must be utilized 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; and
- Robust criteria for monitoring trials to ensure they are making sufficient scientific progress;
- Adequate and appropriate criteria and process for terminating trials that do not meet scientific goals (trials involving rare diseases are excluded)
The Scientific Review and Monitoring Committee (SRMC) is a joint multidisciplinary committee between UF Health Cancer Center (UFHCC) and UF Health Proton Therapy Institute (UFPTI). The committee’s mission is to enhance the quality of cancer research by providing scientific oversight and feasibility review for cancer-related research conducted on our campuses.
The committee will ensure effective allocation of UFHCC, UFHCC-OH and UFPTI resources to support research protocols by evaluating each protocol for:
- Scientific merit
- Risk/benefit ratio
- Biostatical soundness
- Resource utilization
What authority and responsibility does the SRMC have?
The SRMC reviews all studies of cancer or that are specific to patients with cancer that are conducted by faculty, staff or students at the UF Health Gainesville campus and UFPTI. Prospective studies must be reviewed and approved by the appropriate Disease Site Group (DSG) or Research Program prior to SRMC submission. The SRMC ensures that the study design fulfills study objectives and helps principal investigators (PIs) of investigator-initiated clinical trials optimize the scientific value of their studies.
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 if a study demonstrates continued scientific merit and meets satisfactory progress towards achievement of study endpoints. In addition, the SRMC will review all major protocol amendments or study revisions to interventional trials.
During the initial submission and annual reviews, the SRMC may recommend amendments to, or termination of, a protocol. Such reasons include the development of therapy which is superior to that proposed in the protocol or a change in the standard of care which 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), where appropriate.