What authority and responsibility does the SRMC have?
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. They 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.