Protocol Review and Monitoring Committee (PRMC) Submission Requirements
All documents are to be submitted to the PRMC via e-mail to PRMC@med.uvm.edu.
New Research Protocols and Subsequent Amendments
Investigators must obtain approval from both the UVMCC PRMC and the IRB of a new research study. While submission to these committees can be done simultaneously, the UVM IRB will not approve the study until it has received UVMCC PRMC approval. Once
IRB approval has been obtained, please notify the PRMC when you are ready to begin accruing patients. The PRMC will officially “activate” your research study. You must follow this process before you can begin accruing
patients or collecting and/or using specimens and/or questionnaires. This site explains the submission process for the PRMC. For submission guidelines to the IRB, please visit the UVM 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, Industry Sponsored, 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.
What not to Submit to the PRMC: The PRMC does not require submission of retrospective chart-review studies or retrospective health record studies. However, if you are uncertain of whether the study requires PRMC review,
you may contact the PRMC coordinator or submit your study for a pre-review via e-mail to PRMC@med.uvm.edu.
Please note that the PRMC requires that a qualified UVM or The University of Vermont Medical Center faculty member be the Principal Investigator. In the case of a study written by a Medical Student, Graduate Study or Fellow, the Faculty
Sponsor must be listed as a co-PI or co-Investigator.
All cancer related clinical trials at the UVMCC are required to be vetted by the Transdisciplinary Disease Team (TDT) of the study disease type. The TDTs meet regularly to review existing and potential research studies for specific cancer types and to
promote collaboration across departments at UVMCC. The TDT must review and approve a study and complete the PRMC TDT form which is to be signed by the TDT leader and submitted to the PRMC via e-mail at firstname.lastname@example.org. For more information about the PRMC TDT submission process please contact the PRMC coordinator
PRMC Process Overview:
New research studies (initial submissions) will undergo one of three types of reviews: Full Committee Review, Basic Review, or Accelerated Review.
Full Committee Review: A Full Committee Review will occur only at the monthly PRMC meeting with the full committee present. The committee will discuss the scientific merit and design of new cancer research studies. Within
two weeks after this meeting, you will be notified of the Committee's decision. The research study will be either Approved, Approved, pending clarification (no revisions required), Approved, pending minor revisions to the protocol, Tabled until further
clarifications/revisions to the protocol are provided or Disapproved.
Basic Review: Some research studies do not require review at the Full Committee meeting and will undergo a basic review which can occur at outside of the monthly meeting. Those studies include: NCTN (Cooperative Group) studies; registry
studies; and repository studies. It is up to the PRMC Chair if a study requires more discussion after the Basic Review, and in those cases, the protocol will be placed on the next scheduled PRMC monthly meeting, where it will be discussed and voted
upon by the full committee.
Accelerated Review of Protocols: Studies may be eligible for Accelerated Review in cases when time is of the essence (including requests for emergency use and expanded access), the PRMC Chair can call for an accelerated full committee review. Requests for compassionate use of a
study drug will be not reviewed by the PRMC if there is no research data or no data collection is involved. PRMC review will be conducted at the request of the IRB when there is an urgent need for the use of an investigational drug or device
outside of a clinical trial and may grant approval if the following conditions are met:
- There is an eligible patient who requires treatment before the study 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
All study amendments that are submitted to the UVM IRB must be submitted to the PRMC. The PRMC Coordinator in consultation with the Chair will determine whether the amendment requires review by the PRMC. Those amendments that do
not require review will receive an acknowledgement memo and will be filed with the PRMC.
Amendments that involve a change to the science of the study will require review by the Full Committee. The PRMC does not perform expedited or administrative reviews of amendments. The Coordinator in collaboration with the PRMC chair
will make the determination as to the review level an amendment will require.
In addition to scientific review of new studies and amendments, the UVMCC PRMC is responsible for oversight of scientific progress of interventional and observational clinical trials that are open to enrollment. At each monthly meeting, the
accruals for studies that were initially opened during that month will be reviewed by the PRMC (i.e., a study that opened in May 2019 will be reviewed in May 2020, etc.). The PRMC makes note of trials with inadequate accruals, (defined
as <50% of the proposed annual target within the last 12 months). The PI is notified and is asked to provide a justification as to why the study has not accrued. If the PRMC approves the justification, the study will be approved
for another 6 months. If the PI does not provide justification for lack of accrual, or the PRMC determines the justification to be insufficient, the PRMC may decide to close the study.
Closures for all studies must be reported to the UVMCC PRMC twice: once when the protocol is closed to accrual, and then again when the protocol is closed permanently. Closure notification can be sent via e-mail to email@example.com.
Closed to Accrual: Study PIs must notify the PRMC when a study has closed to accrual. This may be done by forwarding the notice of closure from the sponsor, and/or the acknowledgement provided by the IRB as documentation of
Closed Permanently: Study PIs must notify the PRMC when a study has been permanently closed and all data analysis has been completed (if applicable). This may be done by forwarding the notice of permanent closure from
the sponsor, and/or submitting the acknowledgment provided by the IRB as documentation of the permanent closure. Please submit any preliminary or final study results to the PRMC if they are available.