Protocol Review and Monitoring Committee (PRMC) Submission Requirements
Submission of any documents to the PRMC is done online using the UVM Cancer Center Commons.
New Protocols and Amendments to Protocols
You must have approval from both the PRMC and the IRB for your new protocol before you can begin accruing patients or using specimens. This site explains the submission process for the PRMC. For submission guidelines for the IRB, please visit the IRB website.
What to Submit to the PRMC: If you are submitting a new protocol to the PRMC, please click on the type of study in the "Type of Protocols" menu on the right (Investigator-initiated, NCTN group, etc.). If you are submitting an amendment to an existing protocol, please click on the type of protocol on the right menu and scroll to the "Amendment" guidelines.
The PRMC does not require submission of retrospective chart-review studies or retrospective health record studies.
Please note that the PRMC requires that a UVM or The University of Vermont Medical Center faculty member be the Primary Investigator. In the case of a study written by a Graduate Student or Medical Student, the Faculty Sponsor must be listed as a co-PI.
Clinical cancer trials at the UVM Medical Center are required to be vetted by a disease-specific Transdisciplinary Team (TDT). The TDTs meet regularly at the UVM Medical Center to inform providers about all research studies available for patients with a particular cancer type and to promote collaboration across departments at the UVM Medical Center. The TDT must review and approve a protocol (including completion of the TDT Protocol Submission Form) before study documents are completed and submitted to the PRMC. For more information about the TDT, please contact the PRMC Coordinator, Emily Harwood, at 656-2967 or firstname.lastname@example.org.
PRMC Process Overview:
New protocols (initial submission) will undergo one of three reviews: Full Committee Review, Basic Review, or Accelerated Review.
Full Committee Review: The PRMC meets monthly for a Full Committee Review to discuss the scientific merit and design of new cancer research protocols. Within two weeks after this meeting, you will be notified of the Committee's decision. The protocol will be either Approved, Approved Pending Revisions, Tabled, or Denied.
Basic Review: Some protocols do not require review at the Full Committee meeting. Those protocols include: NCTN (cooperative-group) studies; registry studies; and repository protocols. Protocols in those categories are reviewed on a rolling basis under a process called "Basic Review" via email. It is up to the PRMC Chair if a study needs more discussion after the Basic Review, and in those cases, the protocol will be discussed and voted upon at the Full Committee meeting.
Accelerated Review of Protocols
Studies can be eligible for Acclerated Review in cases where there is an immediate need for a patient to enroll onto a study. In those cases, the turn-around time from submission to PRMC approval is ideally within five work days. The PRMC Chair will perform an accelerated review of a new protocol and give approval if the following conditions are met:
- There is an eligible patient who needs treatment before the protocol is scheduled for PRMC review.
- The patient has no other treatment options.
- The patient may benefit from the treatment offered by the protocol.
Review of Amendments
Amendments that involve changing the science of the study will require review by the Full Committee. The PRMC does not perform expedited or administrative reviews of amendments. All amendments to protocols must be submitted to the PRMC Coordinator. The PRMC Coordinator will determine if the amendment requires review by the PRMC.
Some amendment submissions will be acknowledged and filed but not require PRMC Full Committee review. Examples are:
- Minor eligibility changes for participants for the protocol.
- Clarifying the wording in the Informed Consent Form (ICF) or in a survey for the patient.
- Editorial or clarification changes to the ICF in accordance with the IRB's or sponsor's suggestions.
- Changing the target accrual goal for the study.
The following amendments do not need to be submitted to the PRMC:
- Key personnel updates.
- Amendments to study advertisements and recruitment materials.
- Cooperative group (NCTN) amendments.
Please contact the PRMC Coordinator if you are unsure about whether an amendment will require full PRMC review.
Safety Reports and Adverse Event Reporting
All trials, whether investigator-initiated, cooperative group, or industry, must report the following to the University of Vermont Cancer Center;
- All local serious adverse events (SAEs)
- Protocol-related problems and deviations (1 copy via email)
All protocols must include a Data and Safety Monitoring Board or Data and Safety Monitoring Plan.
Depending on the type of protocol and the type of Data and Safety Monitoring Plan, there may be several reporting branches to be followed. Here are some useful links to be aware of when reporting on adverse events:
- The Research Protections Office's Manual for Human Subjects Research.
- For NCI Adverse Event Reporting Guidelines see NCI Adverse Events Guidelines (PDF).
- IRB Unanticipated Problem form..
- If the NCI holds the IND the NCI Guidelines for Expedited Adverse Event Reporting Requirements for NCI Investigational Agents are followed as published in the NCI Investigator Handbook..
- If the NCI is not IND holder the controlling regulations followed are those of the Food and Drug Administration 21 CFR, Part 323.32; Expedited Safety Reporting Requirements for Human and Drug and Biological Products..
- FDA if commercially available agents/devices (no IND involved), reported through FDA Medwatch.
You may also contact email@example.com for technical help and firstname.lastname@example.org for content help.
Quarterly Reports and Study Progress
Cancer protocols must submit accrual data to the UVM Cancer Center on a quarterly basis using the Quarterly Report Form. Registry studies and repository studies that are cancer related must submit information about the study progress on a semi-annual basis using the Study Progress Report Form.
Closures for all studies must be reported to the University of Vermont Cancer Center PRMC twice: once when the protocol is closed to accrual, and then again when the protocol is closed permanently.
Closed to Accrual: Same amendment cover form as required by UVM IRB – Submit one copy when the protocol is closed to accrual (i.e., no longer enrolling patients onto the protocol, but patients may still be receiving treatment, follow-ups, or data analysis per protocol).
Closed Permanently: Continuing Review Form (as required by UVM IRB) and the Final Study Report– Submit one copy when the protocol is completely closed (i.e., patients are no longer being accrued, treated, or followed).