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PRMC Submission Requirements

All documents are to be submitted to the PRMC via e-mail to PRMC@med.uvm.edu.

Protocol Review Resources

Requirements

New Research Protocols and Subsequent Amendments

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Investigators must obtain approval from both the ̽̽CC PRMC and the IRB of a new research study.  While submission to these committees can be done simultaneously, the ̽̽ IRB will not approve the study until it has received ̽̽CC 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 ̽̽ IRB.

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. 

Submission Requirements

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Please note that the PRMC requires that a qualified ̽̽ or ̽̽ 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 ̽̽CC 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 ̽̽CC. 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 prmc@med.uvm.edu.  For more information about the PRMC TDT submission process please contact the PRMC coordinator at prmc@med.uvm.edu.

Process Overview

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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:

  1. There is an eligible patient who requires treatment before the study is scheduled for PRMC review.
  2. The patient has no other treatment options.
  3. The patient may benefit from the treatment offered by the protocol.

Review of Amendments

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All study amendments that are submitted to the ̽̽ 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.

Continuing Reviews

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In addition to scientific review of new studies and amendments, the ̽̽CC 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.

Study Closures

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Closures for all studies must be reported to the ̽̽CC 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 prmc@med.uvm.edu.

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 the closure. 

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.

Due Date

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Protocols must be submitted two weeks prior to the committee meeting. The PRC meets on the 2nd Monday of every month. See a detailed schedule of committee meetings.

There are five (5) types of protocols:

Investigator Initiated

Overview
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Research study protocols that are written by a local principal investigator (PI) and involve an intervention for the patient must be vetted by the appropriate TDT and then reviewed by the PRMC Full Committee.  Investigators are required to submit a fully formatted protocol written according to ICH GCP Guidelines which describes the background, rationale, objectives, design, methodology, statistical considerations, and references which support the research.  The protocol should contain enough information for the committee to conduct a comprehensive scientific review.  The PRMC will not accept an IRB Protocol Summary Template Document.  The IRB will accept the PRMC full protocol document in lieu of their IRB Protocol Summary Template Document to reduce duplication efforts.

Investigators who require assistance with protocol development or who have questions regarding this process can contact the PRMC coordinator at PRMC@med.uvm.edu.

Initial Study Submission
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  • ̽̽CC Protocol Submission Form (PDF).  The PI is responsible for completing the PSF in full.  Submissions will be returned to the PI if the form is not completed in full and signed by the PI.  
  • ̽̽CC Transdisciplinary Team (TDT) New Protocol Form (PDF) The PI must present the proposed clinical trial to the TDT of the study site. This form must be completed in full by the TDT leader or their designee and may be signed by the TDT leader or their designee. .
  • The current version of the protocol, investigator brochure (if available), pharmacy manual (if available) and laboratory manual (if available)
  • All supporting documents for the protocol (for example: Questionnaires, Surveys, etc.) 

Please submit the above documents to the PRMC via e-mail to PRMC@med.uvm.edu.

Submission of Study Protocol Amendments
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Amendments involving scientific changes will be reviewed at the monthly PRMC Full Committee meeting. Amendments that do not require PRMC review will be acknowledged and filed.  An acknowledgement memo will be sent to the regulatory or research coordinator, PI, and IRB, if applicable.

Amendment submissions must include:

Please submit all amendments to the PRMC Coordinator via e-mail to PRMC@med.uvm.edu. 

Other Reporting
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Study closures to accrual and permanent closures must be submitted to the PRMC as per the Submission Requirements.

NCTN and Other Peer-Reviewed Trials

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Studies that are sponsored by the National Clinical Trials Network (NCTN) and other peer-reviewed trials which involve an intervention for the patient must be vetted by the study disease site Transdisciplinary Team (TDT) and then reviewed by the PRMC. Please submit the following via e-mail to the PRMC coordinator via e-mail at PRMC@med.uvm.edu.

Initial Study Submission
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Peer-reviewed trials that are not eligible for NCI Central IRB (CIRB) review, the following must be submitted to the PRMC:

  • ̽̽CC Clinical Research Protocol Submission Form (PDF). The PI is responsible for completing the PSF in full. Submissions will be returned to the PI if the form is not completed in full and signed by the PI.
  • ̽̽CC Transdisciplinary Team (TDT) New Protocol Form (PDF). The PI must present the proposed clinical trial to the TDT of the study site. This form must be completed in full by the TDT leader or their designee and may be signed by the TDT leader or their designee. . 
  • The current version of the protocol, investigator brochure (if available), pharmacy manual (if available) and laboratory manual (if available)
  • All supporting documents for the protocol (for example: Questionnaires, Surveys, etc.) 
Study Protocol Amendments
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Amendments for NCTN studies, (regardless of whether they use CIRB or not) do require PRMC assessment for determination of review.  Should the PRMC determine no review is required, a memo will be issued to the PI confirming receipt of the amendment and with no further action required.  The amendment and memo will be maintained on file with the PRMC.

Please submit all amendments to the PRMC Coordinator via e-mail to PRMC@med.uvm.edu.
 

Other Reporting
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Study closures to accrual and permanent closures must be submitted to the PRMC as per the Submission Requirements.

Industry Sponsored Trials

Overview
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Research studies that are industry sponsored and involve an intervention for the patient must be vetted by the appropriate TDT and then reviewed by the PRMC Full Committee.

Initial Study Submission
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  • ̽̽CC Clinical Research Protocol Submission Form (PDF). The PI is responsible for completing the PSF in full. Submissions will be returned to the PI if the form is not completed in full and signed by the PI.
  • ̽̽CC Transdisciplinary Team (TDT) New Protocol Form (PDF). The PI must present the proposed clinical trial to the TDT of the study site. This form must be completed in full by the TDT leader or their designee and may be signed by the TDT leader or their designee. .
  • The current version of the protocol, investigator brochure (if available), pharmacy manual (if available) and laboratory manual (if available)
  • All supporting documents for the protocol (for example: Questionnaires, Surveys, etc.) 

Please submit the above documents to the PRMC via e-mail to PRMC@med.uvm.edu.

Submission of Study Amendments
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Amendments involving scientific changes will be reviewed at the monthly PRMC Full Committee meeting. Amendments that do not require PRMC review will be acknowledged and filed.  An acknowledgement memo will be sent to the regulatory or research coordinator, PI, and IRB, if applicable.

Amendment submissions must include:

  • Cover letter with rationale for amendment changes.
  • Revised Protocol, if applicable
  • Revised IB, If applicable

̽̽CC Amendment – Transdisciplinary Team (TDT) Review Form (PDF), If applicable

Please submit all amendments to the PRMC Coordinator via e-mail to PRMC@med.uvm.edu. 

Other Reporting
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Study closures to accrual and permanent closures must be submitted to the PRMC as per the Submission Requirements.

Lab-Based, Specimen Collection, or Survey-Designed Studies

Overview
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Lab-based, specimen collection or survey-studies that are studying one or more specific disease groups must be vetted by the study disease site Transdisciplinary Teams (TDT) for each group and then reviewed by the PRMC Committee. 

While the IRB does allow exemptions to these types of studies, these types of study are NOT exempt from PRMC review and submission and subsequent approval of these studies by the ̽̽CC PRMC is required.

Initial Study Submission
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  • ̽̽CC Clinical Research Protocol Submission Form (PDF). The PI is responsible for completing the PSF in full. Submissions will be returned to the PI if the form is not completed in full and signed by the PI.
  • ̽̽CC Transdisciplinary Team (TDT) New Protocol Form (PDF). The PI must present the proposed clinical trial to the TDT of the study site. This form must be completed in full by the TDT leader or their designee and may be signed by the TDT leader or their designee. View TDT meetings.
  • The current version of the protocol, investigator brochure (if available), pharmacy manual (if available) and laboratory manual (if available)
  • All supporting documents for the protocol (for example: Questionnaires, Surveys, etc.) 

Please submit the above documents to the PRMC via e-mail to PRMC@med.uvm.edu.

Study Protocol Amendments
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All amendments will be assessed for level of PRMC review.  Amendments involving scientific changes will be reviewed at the monthly PRMC Full Committee meeting. The Principal Investigator and research coordinator will receive an acknowledgement of amendments that do not require PRMC review, and the amendment will be kept on file with the PRMC.

The following documents are required for amendment submissions: 

  • Amendment summary or cover letter with rationale for amendment changes 
  • Tracked changes version of the revised protocol 
  • Clean version of the revised protocol 


Please submit all amendments to the PRMC Coordinator via e-mail to PRMC@med.uvm.edu.   

Other Reporting
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Study closures to accrual and permanent closures must be submitted to the PRMC as per the Submission Requirements.

Accelerated Review

Overview
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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:

  1. There is an eligible patient who requires treatment before the study is scheduled for PRMC review.
  2. The patient has no other treatment options.
  3. The patient may benefit from the treatment offered by the protocol.
    • Written Request/Justification for Accelerated Approval from the treating physician with prior approval from the IRB.
    • ̽̽CC Clinical Research Protocol Submission Form (PDF) completed in full and signed by the Principal Investigator (PI)
    • A copy of the full Study Protocol
    • Investigator brochure for the study drug (if applicable), Pharmacy Manual (if applicable), and Lab Manual (if applicable)


Review request submission should be emailed to PRMC@med.uvm.edu.