CPC Reviewer Checklist—Orange Form
For protocols that have been re-submitted for review following initial deferral by the CPC.
BREAKDOWN OF REVIEW TYPES AND EXPECTATIONS
Review Type
Reviewer
Directive
Medical
MD or other qualified CPC member
Review with a focus on medical and clinical
merit, clinical research design, and feasibility
Biological
PhD or other qualified CPC member
Review with a focus on NIH peer review criteria
and considerations
Scientific
CPC Staff—Scientific Review Officer
Review with a focus on scientific merit and
alignment with DCI priorities
Statistical
Statistician
Review with a focus on the statistical analysis
plan and validity of the research design
Pharmaceutical
Pharmacist—Investigational
Chemotherapy Service
Review with a focus on clinical merit and details
of study agent handling, dispensing, and
management
Administrative
CPC Staff—Administrator
Review with a focus on compliance with the
administrative requirements of the CPC and DCI
Consent
Patient Advocate
Review with a focus on language and formatting
of the informed consent form
INSTRUCTIONS
1. The Orange Form is a simplified reviewer checklist which aids in the review of protocols that had been deferred
by the CPC following initial review.
2. Reviewers may “jump” to their section of the checklist by clicking on the relevant link in the “Navigation Pane”
to the left of this document. If the “Navigation Pane” is not open in Word, you may find it by clicking on the
“View” tab of at the top of the Word windown. Then select “Navigation Pane”.
3. For each review criterion, reviewers should determine whether the relevant information is consistent in all
protocol-related documents.
4. While using this checklist, a “yes” is assumed if the reviewer does not provide checks for a review criterion. For
most criteria, the answer should be yes.
5. While using this checklist, if a “no” is checked for any review criterion, please provide comments, suggestions,
and concerns at the end of the review section.
6. During completion of the review, some reviewers indicate the scientific merit of the protocol.
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CPC Reviewer Checklist—Orange Form
For protocols that have been re-submitted for review following initial deferral by the CPC.
High:
The research protocol significantly advances a sub-field within cancer research. These protocols
might represent the “top 10%” of protocols. The primary benefit of having “high” scientific merit is
that the protocol becomes eligible for the “IRB FastLane”, in which the CPC coordinates with the
IRB to attempt completion of IRB review within 14 days of CPC approval.
Medium:
The research protocol adds important knowledge to a sub-field within cancer research. However,
the expected impact of the protocol is limited by the stated objectives and/or approach.
Low:
The research protocol adds knowledge that is limited in scope, impact, and/or innovation.
9. During completion of the review, all reviewers suggest a motion for the protocol, as follows:
Approve:
The protocol possesses adequate scientific merit, clinical research
design, data analysis plan, data and safety monitoring plan, and data
management plan. No changes are necessary.
Approve with minor editorial revisions: The protocol possesses adequate scientific merit, clinical research
design, data analysis plan, data and safety monitoring plan, and data
management plan. However, minor revisions requested by the CPC
are required prior to approval.
Approve with modifications:
The protocol meets basic CPC standards and is approvable. However
it requires specific changes requested by the CPC in order to possess
adequate scientific merit, clinical research design, data analysis plan,
data and safety monitoring plan, and data management plan.
Defer*:
In its current state, the protocol is not approvable because the
protocol lacks sufficient detail. The CPC requires additional
information from the PI in order to make a definitive motion.
Moreover, it is anticipated that the CPC’s ability to approve the
protocol will depend on the content in the PI’s response.
Disapprove*:
The protocol is incomplete or suffers from deficits in scientific merit
and/or subject protections.
* Upon submission of PI response and revisions, these protocols must be reviewed at a convened CPC meeting.
10. During completion of the review, a protocol priority score must be approved by the CPC. The protocol priority
score is proposed by the Clinical Research Program leader.
11. Once the review is complete, upload this review checklist into eIRB by doing the following:
A. Open the protocol workspace in eIRB.
B. On the left side of the workspace, click “CPC – Add Review”, and a pop-up screen will appear.
C. From the dropdown list, select a recommended motion.
D. Add comments as needed (these comments will not be seen by study teams).
E. Attach this review checklist by clicking “Add” and selecting the file from the appropriate folder.
F. Click “OK” to approve attachment of the checklist.
G. Click “OK” to complete the review.
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CPC Reviewer Checklist—Orange Form
For protocols that have been re-submitted for review following initial deferral by the CPC.
TIMEFRAME FOR REVIEW COMPLETION
1. All reviews are expected to be completed in ≤ 7 days of assignment.
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CPC Reviewer Checklist—Orange Form
For protocols that have been re-submitted for review following initial deferral by the CPC.
GENERAL CHECKLIST FOR ANY REVIEWER
Materials to Review in Detail: Protocol, eIRB submission, Investigator Brochure, Research Summary, Consent Form
Materials to Review for Consistency: Protocol, eIRB submission, Research Summary, Consent Form
Protocol information
eIRB #:
Full Protocol Title:
PI:
Reviewer Name:
Review Date:
Protocol Description
Summarize the study objectives, design, inclusion/exclusion criteria, and statistical analysis plan
Primary Objective and Secondary/Exploratory Objectives
Research Design and Key Inclusion/Exclusion Criteria
Key Endpoints and Statistical Analysis Plan
Review Considerations:
Please find the document containing initial CPC concerns and PI responses in the protocol workspace in eIRB. This
document is typically found under the “History” tab of the workspace in the “PI&S Submit Changes” activity.
Describe the concerns and problems that led to initial deferral
Describe the modifications and/or response submitted by the PI
Review Criteria:
1. The modifications adequately address all initial concerns
2. Revisions have been made to all relevant protocol-related documents to reflect the modifications
REVIEWER COMMENTS
Comments and Suggestions to PI (these do not require response from PI):
Concerns, Clarifications, and Modifications (these require response from PI):
Scientific Merit:
High
Medium
Low
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CPC Reviewer Checklist—Orange Form
For protocols that have been re-submitted for review following initial deferral by the CPC.
Motion (see Instructions on page 2 for specific definitions):
Approve
Approve with minor editorial revisions
Approve with modifications
Defer
Disapprove
I need to see PI response before protocol is sent to Chair for final approval:
Yes
No
Time Spent Reviewing this Protocol (in 0.25 hour increments):
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