Protocol Review and Monitoring Committee Submission Requirements
There were two announcements in 2015 regarding changes to the PRMC process. One announcement was on June 25, 2015 and the other was November 24, 2015. Please click here to read the June announcement, and click here to read the November announcement.
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 "List 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.
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 involving multiple disciplines 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 multiple disciplines at the UVM Medical Center. The TDT must review and approve a protocol (including completion of the PRMC Protocol Checklist) 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.
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 via email from Emily Harwood, the University of Vermont Cancer Center Compliance Specialist, of the Committee's decision. The protocol will be either Approved, Approved Pending Revisions, Tabled, or Denied. Please refer to the "Procedures" section on the left submenu for more details regarding the PRMC review process.
Basic Review: Some protocols do not require review at the Full Committee meeting. Those protocols include: cooperative-group studies; registry studies; repository protocols; survey studies; non-therapeutic studies; specimen-collection studies; and studies involving an intervention that is of minimal risk to the patient. Protocols in those categories can be reviewed on a rolling basis under a process called "Basic Review." Those protocols can be approved before the full committee meets. In general, Basic Review is a shorter turn-around time from time of submission to PRMC approval. Basic Review occurs separate from the PRMC Full Committee meeting and is done via email or the UVM Commons with Committee members. 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 as a single hard-copy. The PRMC Coordinator will determine if the amendment requires review by the PRMC. The PRMC Coordinator will contact the research coordinator if additional copies and supporting documents, such as an updated Investigatonal Drug Brochure, are required. If the amendment does not need to go to the Full Committee, then the PRMC Coordinator will email the research coordinator acknowledging that the amendment was received and that it does not require PRMC review. This "acknowledgement" is for non-scientific, non-resource related amendments.
Some examples of amendment submissions that will be "acknowledged" and filed but not needing PRMC Full Committee review 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.
Key personnel updates are not required for PRMC submission unless updating the PI or key/primary contact.
Amendments to study advertisements and recruitment materials are not required for PRMC submission.
Cooperative group (NCTN) amendments are not reviewed by the PRMC.
There are amendments made to a protocol because of an update to an Investigator Drug Brochure (IDB), for example, updating the Consent Form due to new risks about a study drug as written in an updated IDB. In those cases, a copy of the updated IDB must be submitted with the amendment.
Please email Emily Harwood if you are unsure about whether an amendment will require full PRMC review. Emily can also be reached at 802-656-2967.
Adverse Event Reporting to the PRMC
All trials, whether investigator-initiated, cooperative group, or industry, must report serious adverse events to the University of Vermont Cancer Center. All local Serious Adverse Events (SAEs) must be reported to the PRMC within 7 days of discovery by email to email@example.com.
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.
The following types of safety reports must be submitted to the PRMC Coordinator (please use the standard IRB Unanticipated Problem Form):
- Protocol-related problems and deviations (1 copy via email)
- Local report for serious adverse events (1 copy via email)
Closures for all studies must be reported to the University of Vermont Cancer Center PRMC / Clinical Trials Office twice: once when the protocol is closed to accrual, and then again when the protocol is closed permanently.
Closed to Accrual: Amendment cover form– 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 AND Final study report – Submit one copy when the protocol is completely closed (i.e., patients are no longer being accrued, treated, or followed)
Last modified March 04 2016 03:51 PM