Scientific Review and Monitoring Committee
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or trials that have become obsolete by new advances in the field and therefore whose scientific rationale has become superseded by clinical practice.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 FC (for CTO-managed protocols only) must provide endorsement.
- What is the SRMC?
- How do I know if my study needs to be submitted to the SRMC?
- What authority and responsibility does the SRMC have?
- When does the SRMC meet?
- How do I submit a study or protocol to the SRMC for review?
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 comprised of researchers from the 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 committee will ensure effective allocation of UFHCC resources to support research protocols by evaluating each protocol for:
- Scientific merit
- Risk/benefit ratio
- Biostatical soundness
- Resource utilization
All studies of cancer relevant studies that are conducted on the UF Health Gainesville campus or UFPTI must be reviewed by the SRMC.
The University of Florida defines a “cancer relevant” study as one that:
- Specifies enrolling patients with a known or suspected diagnosis of cancer as part of the eligibility criteria; or
- Includes research endpoints related to cancer, associated ymptoms or established cancer risk factors (including smoking and tobacco-associated studies, surveys, hepatitis or HPV vaccines, etc.); or
- The local PI plans to exclusively enroll current, former or potential cancer patients into the study
It is difficult to list every possible scenario in which a study would be considered cancer-relevant. In general, this means that it involves cancer patients, uses data, tissue, or blood specimens from cancer patients, or will lead to findings that may be significant to cancer patients. If an investigator is unsure if a study meets cancer-relevant criteria, please contact the SRMC Administrator to determine if the study must be submitted for SRMC review and approval.
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.
The SRMC meets twice per month on the second and fourth Thursday at 4:00 p.m. The meetings are held at the following locations for the two participating sites:
- Gainesville: Urology Conference Room (M2-203)
- Jacksonville: Marco Conference Room
The SRMC utilizes OnCore®, a clinical trials management system to document the submission and electronic routing and workflow tracking system. The Cancer Center Clinical Trials Office is here to assist with initial SRMC submissions. You can upload your study through the protocol assistance form here. Please include all applicable documents to expedite processing.
|Protocol or Investigational Plan||YES||YES|
|Investigator’s Brochure||NO||IF APPLICABLE|
|Completed DSG/RP Approval Form DSG Submission Form||NO||YES|
|Feasibility Group Review Letter||NO||CRO ONLY|
|Draft ICF||NO||UF IITs ONLY|
|SRMC Pre-Review Approval Form UFHCC IIT PreReview Form||NO||UF IITs ONLY|
|Other Relevant Documentation||IF APPLICABLE||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 here.
If you need an OnCore® account, you can request OnCore® User Access.
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 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. 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
- Registries and banking studies without research hypotheses
- Expanded Access Protocols with research hypotheses
- 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 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 percent 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 percent of their annual target following the six-month probationary extension may be subject to immediate closure to accrual.
- If accrual is greater than 25 percent but less than 50 percent 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 percent 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, 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. Please see the SRMC Policies and Procedures Manual for additional details.
Low Accrual CAP Template
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.
SRMC Policies and Procedures Manual
For information related to the SRMC, please contact Timmy Guinn, research administrator, at email@example.com or 352.294.8679