PRMC PROTOCOL CHECKLIST
For Lab-based, Retrospective Specimen, or Survey Protocols
The PI/designee of the proposed study must complete all sections and submit to the
Protocol Review and Monitoring Committee (PRMC) along with the protocol
documents. This protocol checklist is designed for retrospective specimen studies as
well as non-intervention and minimal-risk intervention studies.
Before filling this out: does this protocol impact patient treatment, decisionmaking, or put a patient at more than minimal risk? Yes No
If Yes, complete the PRMC Protocol Checklist for PI/TDT.
If No, complete this checklist and submit it to the PRMC with your protocol.
Study ID and Title:
PI for this study:
Date submitted to PRMC:
Sub-investigators or Faculty Sponsors for this study (if applicable):


Tumor Bank Research Subcommittee meeting date (if applicable):
Brief Description of proposed study (about 3 paragraphs, with hypothesis, objectives, methods, and
special requirements if any):
Please give all pages of this form to the responsible CRA and the PRMC Coordinator, Emily Harwood
(Emily.harwood@uvm.edu).
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Proposed Protocol Identifier: ____________________
I.
Protocol Details
Please ensure the following details are accurately described in the protocol document.
YES
1.
Is there a plan to publish results obtained through this protocol?
2.
Does this study involve any protocol-directed interventions for patients (for
example, surveys, blood draw)?
Does this study prospectively collect samples or specimens?
a) If yes, please describe the sample source(s) and number to be studied:
3.
NO
NA
b) If this study prospectively collects samples, will any remaining specimens be
transferred into the UVM Cancer Center Tissue Biobank?
4.
Will data from patient chart or other clinical records be reviewed or collected?
5.
Will archived tissue be utilized?
If yes, please indicate the source:
___ UVM Medical Center Pathology
___ UVM Cancer Center Tissue Biobank
___ Other institution (requires Materials Transfer Agreement as per UVM
IRB)
Is there a Data and Safety Plan described in the protocol to protect patient
confidentiality?
6.
7.
Is additional staffing/specialist involvement needed?
8.
Has funding been identified to cover the costs associated with the protocol
requirements?
Is this protocol funded by an NIH grant?
If yes, please identify the type of grant:
Additional comments regarding the above questions:
9.
II.
a.
Resource Utilization
Does the protocol utilize UVM Cancer Center (UVMCC) resources (mark those that apply with an X)?
Please note that, before the proposed protocol is submitted, investigators can contact Emily Harwood
at the UVMCC to obtain help with any of the following categories.
Research Coordinator (for help in enrolling
Use of archived specimens from UVMCC Tissue
Biobank (describe in comments and attach the
patients, collecting data, etc.)
results from Tumor Bank Research Subcommittee)
DNA analysis (please describe in comments)
Other Core facilities (please describe in
comments)
Statistical Input (please describe in
comments)
Translational Laboratory (Specimen collection,
PKs, etc.)
Comments:
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Proposed Protocol Identifier: ____________________
b.
Does the protocol utilize UVM Medical Center or UVM institutional resources (mark those that apply
with an X)?
Pathology (blocks, slides, etc.)
Radiology (attach completed
radiology research support form)
Pharmacy
Other (please describe in comments)
Comments:
c.
Please list any outside institutions or organizations that this protocol will use*:
(*may require institutional agreements)
III.
Patient Population Considerations
Review to determine feasibility:
YES
1.
Does this study compete with another active study?
If yes, please explain why this study should be opened:
2.
Please list the other competing studies:
NO
NA
Review of site-specific enrollment goals
Number
A.
Number of anticipated eligible patients/cases per year at the site(s)
B.
Number of anticipated patients/cases to be enrolled/collected per year
C.
Anticipated duration of enrollment period or data collection period
______ months
Or ______ years
PI Signature: ______________________________________________
Date: ________________
Please give all pages of this form to the responsible CRA and the PRMC Coordinator, Emily Harwood,
(Emily.harwood@uvm.edu).
Lab.etc.version.11.23.2015
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