Scientific Review and Monitoring Committee

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 Institute 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).

The SRMC comprises two panels that each meet twice per month: the Biomedical Sciences Panel (BMSP) and the Cancer Control and the Population Sciences Panel (CCPSP). For each panel, there are several levels of review conducted by the SRMC:

Full Committee Reviews

Full committee 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 boar 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

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 and Experimental Therapeutics 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.
• Prospective, Non-Interventional studies
• Annual renewal of cancer studies that have made adequate progress towards accrual goals.

Administrative Reviews

Administrative reviews are conducted on studies that do not qualify for full committee 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
• Registries and banking studies without research hypotheses
• Expanded Access Protocols with research hypotheses
• Single patient IND

Continuation Reviews

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 stated subject accrual goals (both annual and total goals), one of the following decisions will be made:

• If a study is at less than 25% of its annual accrual goal at the initial six-month or any subsequent CR, the study will be placed on a six-month probation period. Studies that are still under 25% of their annual target following the six-month probationary extension 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 justifiable, the study may continue and will be reviewed again in either six or 12 months per the discretion of the chair.
• Studies that have accrued greater than 50% of their annual accrual goal at the six-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, Phase 1 studies, and NCTN studies not meeting accrual goals. An exception to the accrual requirements will be made for studies involving rare cancers. All pediatric oncology clinical trials will be considered rare disease studies.

The SRMC uses OnCore®, a clinical trials management system to document the submission and electronic routing and workflow tracking system. The Cancer Institute Clinical Research Office is available to assist with initial SRMC submissions via an OnCore ePRMS submission.

For teams that are not UF Health Cancer Institute CRO managed, and who are not able to submit to the SRMC using OnCore via the ePRMS submission console, completion of the SRMC intake form will begin the SRMC review process and entry into the OnCore system. Contact the SRMC with any concerns at UFHCI-SRMC@cancer.ufl.edu.

All cancer relevant trials that will be conducted by faculty, staff or students at the UF Health Gainesville campus or the UF Health Proton Therapy Institute must be reviewed by the SRMC prior to activation. In addition, all interventional trials must undergo DSG review and endorsement prior to SRMC review.

Create a new submission.

*If you are not located near the UF Health Science Center (HSC), you will need to use the HSC VPN to access the SRMC Intake Form.

SRMC Required Documents

• SRMC Submission Form
  • Non-interventional: No
  • Interventional: Yes
• Protocol or Investigational Plan
  • Non-interventional: Yes
  • Interventional: Yes
• Investigator’s Brochure
  • Non-interventional: No
  • Interventional: If applicable
• Completed DSG Submission Form
  • Non-interventional: No
  • Interventional: Yes
• Draft ICF
  • Non-interventional: No
  • Interventional: UF IITs only
• I2T3 Concept Review Form
  • Non-interventional: No
  • Interventional: UF IITs only
• Other Relevant Documentation
  • Non-interventional: If applicable
  • Interventional: If applicable

Study teams will require OnCore® access in order to manage their studies post-initial SRMC approval. If you already have an OnCore® account, you can access the system. 

If you need an OnCore® account, you can request OnCore® User Access.