The SRMC provides the critical review of scientific merit, methodology and validity of statistical analyses of cancer-relevant studies prior to activation. The committee will ensure proper prioritization of studies and the ability to monitor all cancer-related studies for expected progress relating to accrual goals and performance standards.
The SRMC also has the authority and charge to close any study not meeting the expected accrual goals or trials that have become obsolete by new advances in the field and therefore whose scientific rationale has become superseded by clinical practice. For a protocol to be reviewed by the SRMC, both the sponsoring DSG/RP and UFHCC Feasibility Group (for CRO-managed protocols only) must provide endorsement.
Following discussion, the Committee votes to Approve, Approve with Stipulations, Table or Disapprove the protocol, meaning:
- Approved: Approved for opening to accrual contingent upon obtaining IRB approval and completion of all other protocol activation steps
- Approved with Stipulations: Study is approvable pending satisfactory responses to reviewer questions and concerns. The initial reviewers will review the PI response to stipulations, and the SRMC Chair or a Co-Chair will provide final approval.
- Tabled: Substantial issues are present and revisions and/or formal reconsideration by SRMC are required.
- Disapproved: The study is not approved for opening.
For information related to the SRMC, please contact Timmy Guinn, research administrator, at email@example.com or 352.294.8679