Protocol Review Committeee Submission Requirements
New Protocols and Amendments to Protocols
You must have approval from both the PRC and the IRB for your new protocol before you can begin accruing patients or using specimens. This site explains the submission process for the PRC. For sumission guidelines for the IRB, please visit the IRB website.
Process Overview: The PRC meets monthly 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, VCC 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 PRC review process.
What to Submit to the PRC: If you are submitting a new protocol to the PRC, please click on the type of study in the "List of Protocols" menu on the right (Investigator initiated, cooperative 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 PRC requires that a UVM or FAHC 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.
Please be advised that any patient who signs a consent form must be registered within 24 hours using Study Manager, the UVM College of Medicine web-based registration system. In addition, when a patient goes off-study, the VCC Clinical Trials Office must be notified within 24 hours using the off-study form in Study Manager. Please contact Emily Harwood at 656-2967 to set up a Study Manager account.
Expedited Review of Protocols
The PRC does not perform expedited reviews of new protocols.
The PRC Chair will review a new protocol and give administrative approval for one (1) patient if the following conditions are met:
- There is an eligible patient who needs treatment before the protocol is scheduled for PRC review.
- The patient has no other treatment options.
- The patient may benefit from the treatment offered by the protocol.
Administrative Review of Amendments
The PRC does not perform expedited reviews of amendments. Amendments to protocols must be reviewed by the full PRC at the monthly meeting. However, some members of the PRC administratively review and approve of minor amendments to protocols every Monday. Such amendments must not change the scientific design or statistical analysis as originally described in the protocol.
Some examples of a minor amendment are:
- Adding research staff to the Key Personnel.
- 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.
Please email Emily Harwood if you are unsure about whether an amendment can be administratively reviewed or if it will require full PRC review. Emily can also be reached at 802-656-2967.
Adverse Event Reporting to the PRC
All trials, whether investigator-initiated, cooperative group, or industry, must report adverse events to the Vermont Cancer Center according to the NCI guidelines. All local Serious Adverse Events (SAEs) must be reported to the IRB and PRC within 5 days of discovery. All local deaths need to be reported to the IRB and PRC within 24 hours of discovery.
This is particularly important for all investigator-initiated treatment trials and multi-center Phase I/II studies. All SAEs at participating sites must report to the coordinating site within 24 hours of discovery and coordinating centers must disseminate this information to the other sites as soon as possible. This is the responsibility of the Primary Investigator.
All investigator-initiated treatment trials or Phase I/II studies must report all serious, unexpected events and Grade 4 and Grade 5 toxicities, both expected and unexpected, within 24 hours of discovery. A full report must be submitted within 5 days of discovery. For studies with a safety officer, the safety officer must sign off that they were aware of the SAE and the corrective action taken. (When reporting SAEs, please use the standard IRB Unanticipated Problem form accompanied by the SAE Transmittal Cover Sheet.)
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 PRC for their monthly meeting:
- Protocol-related problems and deviations (3 copies)
- Local report for serious and non-serious adverse events (3 copies)
- Investigator Drug Brochure Updates (tracked copy if available) and Summary of Changes (3 copies)
- Batched Safety Reports with table of safety report (3 copies)
- Data safety and monitoring report or progress report (3 copies)
Closures for all studies must be reported to the VCC PRC / VCC 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: Amendment cover 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 November 21 2013 03:11 PM