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 clinical trials. The Protocol Review and Monitoring Committee (PRMC) was initially titled the Protocol Review Committee (PRC), established in 1993. The committee was renamed in June 2015. This committee reviews all clinical cancer protocols at the University of Vermont and The University of Vermont Medical Center prior to initiation.

Protocol Development through the UVM Cancer Center Clinical Trial Office

  1. All cancer clinical trials and laboratory studies require the University of Vermont Cancer Center Protocol Review and Monitoring Committee (PRMC) and Institutional Review Board (IRB) approval. We strongly encourage you to seek PRMC approval first. Our office is available at all times to help investigators through this review process. Please contact us for any assistance in this area.

  2. We strongly encourage you to have a statistician review your protocol before it gets submitted to the PRMC. This is often the most time-consuming activity on our committee.

  3. While it can be important to collaborate with other institutions and share important research, from a regulatory standpoint, there are certain stipulations which need to 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 need to be in place first.

  4. Please refer to other areas on the University of Vermont Cancer Center website for specific instructions on the requirements for submission to the PRMC.

  5. Contracts for industry trials must go through the Office of Clinical Trials at UVM Medical Center and/or the UVM Cancer Center Clinical Trials Office therefore it is prudent to contact them first for instructions on this process.

  6. The Clinical Trials Office helps to coordinate all aspects of protocol development, quality assurance, audit readiness, IRB compliance, and following NCI regulated guidelines.

  7. Cancer clinical research involves many collaborations including regulatory staff, research nurses, pharmacists, data managers and principal investigators. Many of the research staff have particular areas of expertise. The University of Vermont Cancer Center office helps to coordinate 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 bio-repositories. 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.

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. Behavioral and nutritional studies that are cancer-related, such as those studies
    that increase behaviors (e.g., cancer screening, food intake), eliminate
    or reduce behaviors (e.g., smoking, sun exposure), and/or improve
    coping and quality of life/reduce the negative effects of treatment.
  7. Interventions to obtain specimens from cancer patients for the sole purpose of
    performing basic laboratory studies related to cancer.
  8. Interventions to obtain specimens from normal subjects for the sole purpose of
    performing basic laboratory research studies related to cancer.
  9. Use of stored specimens from cancer patients or normal subjects for basic laboratory research related to cancer.

Process and Criteria for Prioritizing Protocols

It is the policy of the UVM Cancer Center to give the highest priority to investigator-initiated protocols when enrolling patients. The order of priority is:

  1. Investigator-initiated protocols
  2. Cooperative group protocols
  3. Industry-initiated protocols

Direct competition (e.g. for patient resources) rarely occurs with these groupings to the extent that one protocol is fully deprioritized (e.g., rejected), due solely to concerns of competition. Efforts are made through research program meetings and other interactions of leadership and members to avoid initiation of directly conflicting protocols by investigators. 

If a protocol is determined to compete with another protocol or be of a lower priority, it may be approved by the PRMC but it is noted that it is a lower priority.

Submission of New Protocols

Submission of protocols and forms to the PRMC is done electronically through the UVM Commons. Please contact Emily Harwood at 656-2967 with questions about using the Commons and to create an account to submit documents electronically. The PRMC does not require submission of retrospective chart-review studies or retrospective health record studies.

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One of the most effective methods of assuring you are on the right track with the formatting and development of your cancer protocol would be to contact the clinical research supervisor at the University of Vermont Cancer Center. Our team is here to help you. Please call us at (802) 656-2967.

Model Protocols and Forms

To assist investigators in writing protocols, the University of Vermont Cancer Center Clinical Trials Office has drafted model protocol and informed consent documents. Investigators may use these documents when designing clinical trial protocols, or refer to the Informed Consent Checklist when drafting their own consent forms.