One of the aims of the Clinical Research Office at the University of Vermont Cancer Center is to help medical professionals navigate their protocols through the approval process. We provide data management support, provide on-going quality assurance for our in-house protocols, review cancer-related clinical trials by our Protocol Review Committee and, most importantly, are here to help investigators get their protocols ready for submission.
Protocol Development/Clinical Trial Coordination
- All cancer clinical trials and laboratory studies require the University of Vermont Cancer Center Protocol Review Committee (PRC) and Institutional Review Board (IRB) approval. We strongly encourage you to seek PRC 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.
- We strongly encourage you to have a statistician review your protocol before it gets submitted to the PRC. This is often the most time-consuming activity on our committee.
- 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.
- Please refer to other areas on the University of Vermont Cancer Center website for specific instructions on the requirements for submission to the PRC.
- Contracts for industry trials must go through the Office of Clinical Trials and therefore it is prudent to contact them first for instructions on this process.
- The Clinical Trials Office helps to coordinate all aspects of protocol development, quality assurance, audit readiness, IRB compliance, and following NCI regulated guidelines.
- 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.
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 Committee (PRC) was established in 1993 and reviews all clinical cancer protocols at the University of Vermont and The University of Vermont Medical Center prior to initiation. The Clinical Research Oversight Committee (CROC), established in 1998, provides additional oversight for clinical trials.
Process and Criteria for Prioritizing Protocols
It is the policy of the Cancer Center to give the highest priority to investigator-initiated protocols when enrolling patients. The order of priority is:
- Investigator-initiated protocols
- Cooperative group protocols
- 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 but it is noted that it is a lower priority. In addition, High Priority (HP) protocols (including HP cooperative group protocols) will be noted on the list of active protocols available to physicians/surgeons on the University of Vermont Cancer Center website. This list of current clinical trials will be updated on the University of Vermont Cancer Center website soon (as of March 1, 2013, the list is under construction).
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.
- Enrollment Form (PDF)
- Protocol Templates from NCI
- PRC Protocol Cover Form
- Common Protocol Cover Form (IRB)
- Modality Sign-off Sheet
- Laboratory Based Form
- SAE/Protocol Deviation Transmittal Sheet (PDF)
- Unanticipated Problem Form (formerly called the "Serious Adverse Event, or SAE form") (IRB)
- Quarterly Report Form
Last modified March 25 2015 03:06 PM