Reviews and Monitoring
Levels of SRMC Review
Full board reviews are conducted for the following protocol types:
- All Investigator Initiated Interventional Trials (IITs)
- New industry, external academic or foundation-sponsored Interventional cancer research studies that have not previously undergone external peer review by one of the NCI approved groups or via a NCI-approved external PRMS.
- Study amendments for full board protocols, which include: 1) addition/reduction of subject accrual goals; 2) changes in methods, procedures or study design; 3) modifications in drug dosage or delivery; 4) changes in exclusion or inclusion criteria; 5) addition of sub-site(s) for IITs; 6) change of Principal Investigator; or other major changes
- Annual renewal of cancer studies that have not made adequate progress towards accrual goals.
Expedited reviews must include the same documents as a full-review, but are only reviewed by the SRMC for confirmation of DSG approval and feasibility. Expedited reviews are conducted for the following submissions:
- NCI-approved National Clinical Trials Network studies.
- Other trials that have been peer-reviewed by one of the NCI approved groups or via a NCI-approved external PRMS. A list of approved organizations can be found here.
- Prospective, Non-Interventional studies
- Annual renewal of cancer studies that have made adequate progress towards accrual goals.
Administrative reviews are conducted on studies that do not qualify for full board or expedited review. It is the responsibility of the SRMC coordinator to review the study to confirm that a study meets the criteria for administrative review. Studies that qualify for administrative review are exempt from further SRMC review. Administrative reviews are conducted for the following submissions:
- Retrospective, Non-Interventional studies
- Studies that meet criteria for IRB exempt status
- Single patient IND
Continuation Reviews will be performed for all interventional trials that are open to accrual. CRs are not required for Non-Interventional studies or Interventional studies that are closed to accrual.
After the committee reviews the study accrual goals as compared to the confirmed subject accrual, one of the following decisions will be made:
- If a study is at less than 25% of its annual accrual goal at the initial 6-month CR, a justification for continued accrual and corrective action plan (CAP) must be submitted to the SRMC. The study will be placed on a 6-month probation period. Studies that are still under 25% of their annual target following the 6-month probationary extension may be subject to immediate closure to accrual.
- If a study is at less than 25% of its annual accrual goal at a subsequent CR, a justification for continued accrual and CAP must be submitted to the SRMC. If the explanation and CAP is deemed satisfactory to the SRMC, the study may continue and be reviewed again in 6 months. Otherwise, the study may be subject to immediate closure to accrual.
- If accrual is greater than 25% but less than 50% of the study’s annual target during any review period, a justification for continued accrual and CAP must be submitted to the SRMC. If the explanation and CAP is deemed satisfactory to the SRMC, the study may continue and will be reviewed again in either 6 or 12 months per the discretion of the Chair.
- Studies that have accrued greater than 50% of their annual accrual goal at the 6-month or annual CR will be granted expedited approval and will be reviewed again in 12 months and then annually.
Special consideration will be given for IITs, including national protocols where UF faculty serve in a leadership capacity, and NCTN studies not meeting accrual goals. The SRMC will make recommendations to enhance recruitment whenever possible.
An exception to the accrual requirements will be made for studies involving rare cancers as defined per the NCI rare disease definition. All pediatric oncology clinical trials will be considered rare disease studies.
Following discussion, the Committee votes to Approve, Approve with Stipulations, Table or Disapprove the protocol
- 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.