UIC
The University of Illinois at Chicago Cancer Center
Protocol Review Committee (CC-PRC)
Policies & Procedures
Effective July 1, 2004
These modified policies and procedures follow the September 2003 National Cancer Institute
(NCI) guidelines for NCI-designated cancer centers. The NCI guidelines require cancer centers to
have a qualified review and monitoring committee with sufficient size and breadth of expertise to
conduct a critical, fair review of all clinical research protocols comprising the cancer center.
The CC-PRC is a multidisciplinary committee of 15 full members. A meeting quorum is declared
when seven full members are present. A registry of ad hoc members and their scientific expertise is
maintained and upgraded continually. The UIC CC-PRC meets bi-weekly. The meeting schedule
is posted on the Cancer Center web site: http://www.uic.edu/com/cancer.
CC-PRC reviews take the place of departmental reviews for UIC Cancer Center members. Cancer
Center members submitting protocols to the CC-PRC are expected to complete all required forms
for the UIC Institutional Review Board (IRB) and CC-PRC.
1.0
Function of Cancer Center Protocol Review Committee
1.1 Conduct a full scientific review of all new institution-initiated cancer research not
already peer reviewed and supported by NIH mechanisms or NCI CTEP or Cancer
Control Protocol Review Committee, including basic, clinical, and cancer control and
population research specified in section 3.0.
1.2 Conduct a feasibility review of new and continuing cancer clinical trials protocols that
have already been peer reviewed and supported by NIH mechanisms (RO1s, UO1s,
PO1s and P50s) and clinical research protocols approved by NCI’s CTEP or Cancer
Control Protocol Review Committee.
1.3 Assist PIs with resubmission by providing written reviews with constructive and clear
feedback.
1.4 Prioritize competing protocols from all sources, including those initiated at UIC and
those initiated by cooperative groups and industry.
1.5 Monitor all clinical cancer research protocols for sufficient progress, including
adequate accrual rates.
1.6 Monitor all clinical protocols for compliance with all the requirements established by
the regulatory bodies, such as the FDA and CTEP guidelines for toxicity reporting,
definition of outcomes, definitions or response/progression, relapse, and adequacy of
trial.
1.7 Terminate cancer clinical protocols not achieving scientific and accrual goals.
1.8 Review and recommend changes to CC-PRC function, policies, and procedures to the
Cancer Center Executive Committee.
Note: CC-PRC will not make a determination based on informed consent and HIPAA documents as these are
covered under IRB review. The CC-PRC reviewers may provide non-binding suggestions to the PI related to
informed consent and HIPAA.
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UIC
The University of Illinois at Chicago Cancer Center
2.0
Protocols Not Eligible for Review by the CC-PRC
2.1 Single case compassionate use protocol.
2.2 Treatment/management guidelines not asking a research question.
2.3 Surveys of healthy subjects and the general population and population-based studies
that do not involve UIC patients, patient tests, drugs or procedures, and/or do not have
endpoints related to cancer.
2.4 Secondary analysis of registry data.
2.5 Protocols that exclusively deal with established cell lines available in the public
domain.
3.0
New Protocols Eligible for Review by the CC-PRC
3.0.1 All new cancer-related studies initiated at UIC or by UIC faculty that have not
already been peer reviewed and supported by NIH mechanisms and NCI CTEP or Cancer
Control Protocol Review Committee involving cancer patients, or involving individuals at
increased risk of cancer, who are diagnosed and/or treated at the UIC or the Veteran’s
Administration Chicago HealthCare System (VACHCS) will have a full review (scientific
and feasibility) by CC-PRC prior to IRB submittal.
3.0.2 All new cancer clinical trials protocols that have already been peer reviewed and
supported by NIH mechanisms (RO1s, UO1s, PO1s, and P50s) and clinical research
protocols approved by NCI’s CTEP or Cancer Control Protocol Review Committee will be
submitted to the CC-PRC and the IRB in parallel. The CC-PRC review will be limited to
feasibility (accrual projections, investigator qualifications, conflict of interest, etc.).
3.0.3 Any clinical cancer research at UIC or VACHCS involving UIC faculty and dealing
with human cancer subjects treated with these modalities:
- Transplants
- Immunotherapy
- Chemotherapy
- Gene therapy
- Surgery
- Radiotherapy
3.0.4 All clinical research studies at UIC or VACHCS involving UIC faculty researching
chemoprevention of cancer using either synthetic or naturally occurring products or
prevention of cancer involving currently accepted methods of treatment (e.g., prophylactic
mastectomies in high-risk breast cancer patients).
3.0.5 Any clinical trial dealing with pain control or prevention, infection control and/or
prevention, or nutrition support for cancer patients, or any cancer-related protocol dealing
with humans to be performed at UIC or VACHCS.
3.0.6 All protocols requiring the use of human tumor specimens, or blood and serum,
specimens from cancer patients.
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UIC
The University of Illinois at Chicago Cancer Center
3.0.7 All retrospective chart reviews of UIC patients with endpoints related to cancer.
3.1
Submittal Process for New Protocols
3.1.1 Three copies of all new cancer-related studies initiated at UIC or by UIC faculty that
have not already been reviewed and supported by NIH mechanisms and the NCI CTEP or
Cancer Control Protocol Review Committee must be submitted to the CC-PRC before the
IRB.
3.1.2 Two copies of all new cancer clinical trials protocols that have already been peer
reviewed and supported by NIH mechanisms (RO1s, UO1s, PO1s, and P P50s) and clinical
research protocols approved by NCI’s CTEP or Cancer Control Protocol Review
Committee should be submitted to the CC-PRC. These protocols can be submitted to the
IRB at the same time.
Submit CC-PRC protocols to:
UIC Cancer Center
Room 237 MCA
814 S. Wood Street (MC 700)
Chicago, IL, 60612
Attn: CC-PRC
PIs are strongly encouraged to consult with a statistician prior to original submission.
Craig Beam, Ph.D. from the School of Public Health in the Division of Epidemiology and
Biostatistics is available to provide statistical help to all PIs (312-996-1589).
3.2
Review Process for New Protocols
3.2.1 The CC-PRC chair assigns all new cancer-related studies initiated at UIC or by UIC
faculty that have not already been peer reviewed and supported by NIH mechanisms and
NCI CTEP or Cancer Control Protocol Review Committee (see section 3.0.2) to a primary
and a secondary reviewer. Protocols that have already been peer reviewed by NIH
mechanisms and the NCI CTEP or Cancer Control Protocol Review Committee will be
assigned to one primary reviewer. Protocols that fall outside the expertise of the CC-PRC
members are assigned by CC-PRC Chair to one or two ad hoc reviewers. In general, the
review process follows the guidelines set forth by various NIH study sections. If
appropriate, a biostatistician will also be assigned. When review by a biostatistician is
required, these factors will be evaluated: 1) The endpoints of the study; 2) Patient
characteristics that may affect response; 3) The design of the study; 4) Sample size and
statistical power to test the hypothesis; 5) A plan for data management; 6) Method(s) for
data analysis; 7) Criteria for stopping the trial. When the biostatistician does not approve
the statistical component of a given proposal, the CC-PRC Coordinator will arrange a
meeting between the biostatistician and the PI to clarify the concerns noted by the
biostatistician so a revised proposal can be submitted within a reasonable time frame.
3.2.2 The CC-PRC makes a determination and assigns a merit descriptor based on:
• Clarity of presentation
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UIC
The University of Illinois at Chicago Cancer Center
• Rationale: Sufficient material is included to justify the proposed protocol
• Research objectives: The primary and secondary objectives are clearly stated and
reasonably achievable by the study
• Eligibility and study requirements: An appropriate study population is clearly
defined and feasible.
• Treatment or study plan: Protocol treatment is clearly specified, as are
modifications to be made on the basis of toxicity, modifications which may be
made at the discretion of the (PI), and criteria for removing a patient from protocol
treatment.
3.2.3 Outcomes from initial CC-PRC review:
• Approved: Approved for opening to accrual contingent upon obtaining IRB
approval and completion of all other protocol activation steps; approved by the full
CC-PRC.
• Modifications Required: Approval from the CC-PRC, but the PI needs to address
minor issues. The CC-PRC Chair, or a designee will provide final approval.
• Deferred Due to Overlap: The PI will be asked to provide a rationale for
approving competing protocols. However, the final decision will be made by the
CC-PRC in consultation with the CC Executive Committee.
• Deferred Due to Scientific Reason: There are sufficient problems with the
protocol and substantial revisions and formal reconsideration by the CC-PRC are
required. The CC-PRC members will try to assist the PI(s) in revising the proposal
for resubmission. The final decision will be made by the full CC-PRC.
• Disapproved: The protocol is not approved for opening to accrual at UIC.
4.0
Continuing Protocols Eligible for Review (CC-PRC and IRB in Parallel)
4.0.1 Upon receipt of the IRB notification that a continuing review report is due and in
accordance with the IRB approval period (no less than once a year), the UIC IRB
Continuing Review of Research Form and the CC-PRC Continuing Review
Submission Form should be completed. Two copies should be submitted to the CCPRC. The protocol can be submitted to the UIC IRB at the same time.
4.0.2 Continuing reviews for institution-initiated and industry-sponsored studies must
include the original protocol, a description of significant revisions, and an update on
accrual progress. If the UIC Accrual goal is significantly less than anticipated, a
rationale for keeping the trial open needs to be included.
4.0.3 Continuing reviews for clinical trials protocols that have already been peer reviewed
and supported by NIH mechanisms (RO1s, UO1s, PO1s, and P P50s) and clinical
research protocols approved by NCI’s CTEP or Cancer Control Protocol Review
Committee need to report on accrual progress. If the UIC accrual goal is
significantly less than anticipated, a rationale for keeping the trial open needs to be
included.
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UIC
The University of Illinois at Chicago Cancer Center
4.0.4 A continuing review is required when accrual is closed and long-term follow-up is
required.
4.1
Review Process for Continuing Protocols
4.1.1 The CC-PRC chair will assign the continuing review to a primary reviewer, and if
appropriate, a biostatistician. The reviewer’s critique will be distributed to CC-PRC
members for discussion at the next CC-PRC meeting.
4.1.2 Factors considered by the CC-PRC during the annual continuing review:
• Accrual
• Toxicity
• Adherence to regulatory guidelines and protocol
• Prioritization
• Continued scientific merit (only for institution-initiated and industry sponsored
protocols not already peer reviewed by a NIH or NCI mechanism (Section 4.0.2)
4.1.3 Outcomes from the CC-PRC continuing review:
• Approved: Approved for continuation contingent upon IRB approval.
• Modifications Required: Approval from the CC-PRC, but the PI needs to address
minor issues. The CC-PRC Chair, or a designee will provide final approval.
• Deferred Due to Overlap: The PI will be asked to provide a rationale for
approving competing protocols. However, the final decision will be made by the
CC-PRC in consultation with the CC Executive Committee.
• Deferred Due to Scientific Reason: There are sufficient problems with the
protocol and substantial revisions and formal reconsideration by the CC-PRC are
required. The CC-PRC members will assist the PI(s) in revising the proposal for
resubmission. The final decision will be made by the full CC-PRC.
• Termination: The protocol is not approved for continuation due to any of these
circumstances:
- Subject accrual has been met and there is not a requirement for follow-up.
- New scientific findings have obviated the need for the protocol.
- Conduct of the research is of such poor quality as to make the findings of
the protocol questionable.
- Patient accrual expectations have not been met.
5.0
Notification of CC-PRC Review Outcome
The CC-PRC review outcome will be emailed to the PI and their research coordinator no
later than two working days following a meeting. A hard copy of the signed approval letter
and a copy of the CC-PRC Reviewer form(s) will be delivered to the PI no later than 3
working days after a meeting.
When the protocol is approved, the PI will include the CC-PRC letter and related CC-PRC
form with the IRB submission. If the CC-PRC letter is not included, the IRB may return the
IRB submission as incomplete.
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The University of Illinois at Chicago Cancer Center
When the protocol is not approved, the PI has the option of contacting the CC-PRC
reviewers for assistance with resubmission. When the protocol is resubmitted, it must be
returned with the original assigned CC-PRC or IRB number.
When the PI is not planning to respond to a CC-PRC decision of "modifications required”
or “deferred," the PI will notify the CC-PRC in writing.
6.0
Amendments
6.1 The CC-PRC and the UIC IRB will conduct a parallel review of two types of
amendments for institution-initiated and industry trials only:
• Changes to the research protocol, including subject enrollment
• Investigator Brochure Updates
The UIC IRB Amendment Form and the CC-PRC Submission Form should be
completed, including any additional information to assist the reviewer.
The CC-PRC chair will assign the amendment to a primary reviewer, and if
appropriate, a biostatistician. The reviewers’ critiques will be distributed to CC-PRC
members for discussion at the next CC-PRC meeting.
6.2 All other amendments should be submitted to the IRB for review and approval.
6.3 When there is a change in the PI, the CC-PRC should be notified by a letter
identifying the new and previous PI.
7.0
CC-PRC Prioritization Procedure
The CC-PRC will give first priority to meritorious clinical protocols. If there are two or
more conflicting proposals or there is evidence of possible overlap between two proposals,
the prioritization schema will strictly depend on scientific merit, the possibilities of
answering logical questions within a reasonable timeframe, as well as the impact on the
medical and general public. The mechanism of prioritization will be based on a plan
devised by the Cancer Center Executive Committee in consultation with the CC-PRC and
will periodically be assessed to maintain impartiality and objectivity.
8.0
Termination of a Protocol by PI
When a PI closes or terminates a protocol, a letter should be sent to the CC-PRC stating
that the research in no longer ongoing.
9.0
Reportable Events-Adverse Events (AE)/Serious Adverse Events (SAE) by PI
The PI of an ongoing study is responsible for reporting all reportable events to the CC-PRC
in the context of the continuing review application. Refer to the following for additional
guidance on reportable events that may pertain to your study protocol:
o UIC IRB: http://www.uic.edu/depts/ovcr/oprs/Guidelines/adverse_event.html
http://www.uic.edu/depts/ovcr/oprs/Forms/Forms/Word/aeform.doc
o Your study protocol
o The sponsor’s Drug and Safety Monitoring Board (DSMB)
o Food and Drug Administration (FDA): http://www.fda.gov
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UIC
The University of Illinois at Chicago Cancer Center
o Office for Human Research Protection (OHRP):
http://ohrp.osophs.dhhs.gov/irbasur.htm
10.0
CC-PRC Appeal Process
PIs can appeal a CC-PRC decision of disapproval or termination of protocol closure by
submitting a written request for a re-review to the CC-PRC Chair. After the re-review, the
CC-PRC can reverse the decision, ask for further revisions, call for an external review, or
ratify the original decision.
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