Protocol Review

Protocol Review and Monitoring System

The University of Vermont Cancer Center's Protocol Review and Monitoring System (PRMS) provides a centralized system for review and monitoring of cancer clinical trials. The Protocol Review and Monitoring Committee (PRMC) is a multidisciplinary committee charged with evaluating the scientific merit of cancer-related clinical research at the University of Vermont Cancer Center.    The PRMC has the authority to approve and authorize activation of cancer research studies which should align with the scientific priorities of the University of Vermont Cancer Center (UVMCC).  The PRMC does not duplicate or have overlapping responsibilities with IRB(s) or the UVMCC Data Safety Monitoring Committee (DSMC).

Protocol Development through the UVM Cancer Center Clinical Trial Office (CTO)

1. All cancer clinical trials and laboratory studies require the UVMCC PRMC and Institutional Review Board (IRB) approval. We strongly encourage you to seek PRMC approval first. Our office is always available to help investigators through this review process. Please contact us via e-mail at PRMC@med.uvm.edu for any assistance in this area.
2. The new study submission to the PRMC must include a fully formatted protocol written according to ICH GCP Guidelines which describes the background, rationale, objectives, design, methodology, statistical considerations, and references which support the research.  The protocol should contain enough information for the committee to conduct a comprehensive scientific review.  The PRMC will not accept an IRB Protocol Summary Template Document.  The IRB will accept the PRMC full protocol document in lieu of their IRB Protocol Summary Template Document to reduce duplication efforts.
3. We strongly encourage you to have a statistician review your protocol before it is submitted to the PRMC. This is often the most time-consuming activity on our committee.
4. While it can be important to collaborate with other institutions and share important research, from a regulatory standpoint, there are certain stipulations which must be addressed. If you think you are going to involve other sites with your research, please let the clinical research office know as soon as possible as there are amendments and agreements which must be in place first.
5. Please refer to other areas on the UVMCC website for specific instructions on the requirements for submission to the PRMC.
6. Contracts for industry trials must go through the Office of Clinical Trials at UVM Medical Center and/or the UVMCC CTO therefore it is prudent to contact them first for instructions on this process.
7. The CTO helps coordinate all aspects of protocol development, quality assurance, audit readiness, IRB compliance, and adherence to NCI regulated guidelines.
8. Cancer clinical research involves many collaborative efforts including regulatory staff, research nurses, pharmacists, data managers and principal investigators. Many of the research staff have specific areas of expertise. The UVMCC CTO office will assist in the coordination of the best teams possible.

Role of the Protocol Review and Monitoring Committee (PRMC)

The PRMC reviews clinical research focused on cancer as well as research using specimens from human subjects, either prospectively or retrospectively. The clinical research may be interventional or observational in design. The research may also be designed to evaluate the delivery, process, management, organization, or financing of health care regarding cancer patients. The PRMC also reviews cancer registry studies and biorepositories. The PRMC does not review non-human laboratory studies (such as mouse or cell-line studies). The PRMC also does not review retrospective chart review studies.

Cancer-related clinical research that must be reviewed by the PRMC includes but is not limited to the following:

1. Physical interventions for the treatment, staging or diagnosis of cancer or cancer-related problems.
2. Physical interventions for the prevention of cancer.
3. Physical and non-physical interventions for the determination, management, and study of cancer risk in normal subjects.
4. Physical interventions for the detection of cancer in normal subjects.
5. Diagnostic tests that affect medical decision-making for the cancer patient.
6. Interventions involving exercise.
7. Behavioral and nutritional studies that are cancer related.
8. Studies involving only surveys/questionnaires, voice, or video recordings.
9. Interventions to obtain specimens from cancer patients and/or normal subjects for the sole purpose of performing basic laboratory studies related to cancer.
10. Use of stored specimens from cancer patients and/or normal subjects for basic laboratory research related to cancer.

Process and Criteria for Prioritizing Protocols

It is the policy of the UVMCC to assign the highest priority to investigator-initiated protocols when enrolling patients. The order of priority is:

1. UVMCC Investigator-initiated Trials (IITs)
2. Any externally sponsored IIT
3. Any other trial (e.g., Industry-sponsored trials, National Clinical Trial Network (NCTN) trials, etc.)

If a UVM investigator is a co-PI on the study development team for a study of any category, the priority of the trial may be increased on a case-by-case scenario.  Prioritization may also depend on the Transdisciplinary Team’s (TDT’s) individualized needs for a balanced portfolio across study types.  

In circumstances where two competing trials would otherwise be similarly prioritized, interventional trials and those that have the highest potential to be of benefit to the research subject or patient should be favored. 

Submission of New Research Studies

Submission of research studies and forms to the PRMC is done electronically via e-mail to prmc@med.uvm.edu. The PRMC does not require submission of retrospective chart-review studies or retrospective health record studies.