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)
Clinical Trials Review Committee
- Chair: Hedy Kindler, MD
- Vice Chair: Russell Szmulewitz, MD
The committee meets monthly (meeting and submission dates, and information about accessing forms can be obtained from the PRMS Manager, Amber Burnett — 5-0352, aburnett@medicine.bsd.uchicago.edu)
The following documents must be provided to the PRMS Coordinator:
- A complete protocol and investigator brochure (if applicable). 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 CTRC 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
Protocols that have undergone external peer review, for example, NIH, ACS, or cooperative group, are eligible for expedited CTRC review, as are Compassionate Use Protocols, registry or banking studies and retrospective studies (contact the PRMS Manager Amber Burnett – 5-0352, aburnett@medicine.bsd.uchicago.edu, for information on how to determine if the protocol is eligible for expedited review).
The CTRC 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 feasibility of completion
Protocols may be:
- Approved
- Approved with revisions
- Deferred
- Disapproved
Principal investigators (PIs) receive a letter notifying them of the Committee’s determination, and next steps.