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A Comprehensive Cancer Center Designated by the National Cancer Institute

Protocol Review and Monitoring System

Introduction
The UCCCC Protocol Review and Monitoring System (PRMS), an NCI-mandated activity, reviews the scientific merit, scientific priority, and scientific progress of all cancer clinical trials conducted at the University of Chicago, regardless of sponsorship, department, or type. The UCCCC PRMS is comprised of two committees: the Clinical Trials Review Committee (CTRC), which conducts the initial protocol review and the Scientific and Accrual Monitoring (SAM) Committee, which is responsible for annual reviews to evaluate scientific progress and study accrual.  Both are under the overall management of the UCCCC Associate Director for Clinical Sciences and the Clinical Research Advisory Committee (CRAC) (see Figure 1).  For cancer-related trials, IRB approval is not granted until the protocol has received CTRC 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.

Clinical Trials Review Committee:

  • Chair: Sue Cohn, MD; Vice Chair: Hedy Kindler, MD
  • 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, the Data and Safety Monitoring (DSM) plan must include procedures for managing 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 review, for example, NIH, FDA, ACS, or cooperative group, are eligible for expedited CTRC review, as are Compassionate Use Protocols, registry or banking studies and other 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 data and safety monitoring plan of the protocol; and the scientific priority in the context of the priority tree, and feasibility of completion.
  • Outcome:  Protocols may be: Approved, Approved with Revisions, Deferred or Disapproved; PIs receive a letter notifying them of the Committee’s determination, and next steps.

Scientific and Accrual Monitoring (SAM) Committee

  • Chair: Chuck Rubin, MD; Vice-Chair: Lucy Godley, MD, PhD
  • Meets monthly; studies are reviewed at the time of IRB Continuing Renewal
  • The SAM review assesses the overall progress of the study as well as data and safety monitoring, including: rate of overall accrual (compared to the projected rate of accrual) and likelihood of successful completion, minority accrual, amendments, compliance with data and safety monitoring policies, and past protocol audits.
  • All data are pulled from existing sources (e.g. Velos, IRB database) and no preparation is required by the PI.
  • Outcome: Protocols may be: Approved, Decision Deferred – pending clarification or corrective action plan from PI, or Recommended for Closure; PIs receive a letter notifying them of the Committee’s determination, and next steps.

 

Walter Stadler

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