Protocol Review and Monitoring System
The Comprehensive Cancer Center Protocol Review and Monitoring System (PRMS), an NCI-mandated activity, reviews the scientific merit, priority, and progress of all cancer clinical trials conducted at the University of Chicago, regardless of sponsorship, department, or type.
The Comprehensive Cancer Center PRMS comprises two committees:
- Protocol Review Monitoring Committee - A
- Protocol Review Monitoring Committee - B
The overall goal of the Protocol Review and Monitoring Committees is to provide internal oversight of the scientific aspects of all clinical research, including the population sciences, conducted at and/or coordinated by the University of Chicago Medicine Comprehensive Cancer Center (UCCCC) and its network sites.
The committees have identical responsibilities, which consist of reviewing:
- Newly proposed prospective cancer-related research
- Significant amendments to ongoing clinical trials
- Continued subsequent assessment for actively enrolling and suspended trials every 6-12 months
Both are under the overall management of the Comprehensive Cancer Center Director and the Protocol Review and Monitoring System Executive Committee (PRMS-EC). For cancer-related trials, institutional review board (IRB) approval is not granted until the protocol has received PRMC approval. In addition, the PRMS has the authority to close trials that do not demonstrate adequate scientific progress based on poor accrual or other factors.
Protocol Review Monitoring Committee - A
- Chair: Andrzej Jakubowiak, MD, PhD
- Vice Chair: Nora Jaskowiak, MD
Protocol Review Monitoring Committee - B
- Chair: Jill de Jong, MD, PhD
- Vice Chair: Christina Bestvina, MD
The committee meets monthly (meeting and submission dates, and information about accessing forms can be obtained from the PRMS Manager, Amber Burnett — 4-0357, aburnett@bsd.uchicago.edu)
The following documents must be provided to the PRMS Coordinator (Amber Burnett) via email:
- A complete protocol. If this is a multi-institutional study coordinated by the UCCCC, the Data and Safety Monitoring (DSM) plan must include procedures for managing Serious Adverse Events (SAE's) from affiliate participating institutions.
- A completed PRMC Clinical Trials Submission Form
- A disease-specific protocol priority tree indicating where the proposed study fits relative to other open studies in that disease area or program
- First-Stage Review Form
- Investigator Brochure (if applicable)
In addition to the above, the trial must be registered in the Cancer Center CTMS (Oncore) prior to PRMC review.
Protocols that have undergone external peer review are eligible for expedited PRMC review, for example:
- National Institute of Health review including studies coordinated by national cooperative groups (e.g. Alliance, NRG)
- Other recognized peer funding organizations (see list here)
- Expanded Access Studies (Treatment given as part of a multi-patient expanded access, compassionate use, or rollover protocol.)
The following protocols are eligible for administrative review:
- Epidemiologic Studies
- Observational Research (including long-term follow-up)
- Health Services Research
- Prospective Data or Sample Collection Research (Prospective projects with specific cancer-related outcomes and which require participant-informed consent and/or which can be linked to identifiable participant data.)
The following protocols are exempt from PRMC review:
- Retrospective Research
- Single Patient Treatment
- Biobanking Registry Studies with no formal hypothesis
- Use of anonymized specimens or data
- Population-/Cohort-Based Research
- Other IRB-Exempt Research
The PRMC review evaluates:
- Background and rationale
- Scientific objectives
- Adequacy of the study design, including primary endpoints and statistical plan
- Adequacy of the data and safety monitoring plan of the protocol
- The scientific priority in the context of the priority tree, and the feasibility of completion
- Amendments that significantly impacts the protocol design (e.g., adding and removing study drug, adding and removing treatment arms, increasing or decreasing the sample size, etc.).
Protocols may be:
- Approved
- Approved with Documentation
- Approved with revisions
- Deferred
- Disapproved
Principal investigators (PIs) receive a letter notifying them of the Committee’s determination and the next steps.