Trial Resource Utilization Committee (TRUC)

TRUC review is now required for all studies prior to CPRC application except the following:

  • Retrospective Chart Review
  • Retrospective Sample Review
  • Prospective Data Registry
  • Prospective Specimen Repository

TRUC Initial Application 

TRUC Submission Deadlines

TRUC Prioritization Algorithm

TRUC Prioritization Algorithm

TRUC Review Process

TRUC Review Process

TRUC Mission

TRUC Mission

The NCI requires that the Masonic Cancer Center review and prioritize all cancer-related trials. Previously, ISC teams have facilitated this process by reviewing trials at the start of the protocol process. Feedback from Principal Investigators has highlighted the need for a more consistent and timely review method. Thus, in order to fulfill the NCI mandate, provide consistency in reviews, and expedite the review and approval turnaround-time within the protocol approval process, the MCC Executive Cancer Research Leadership (Exec CRL) Committee has developed an improved process for this initial review. The purpose of this review is to fulfill the NCI requirement and to provide timely and helpful feedback to PIs. The new Trial Resource Utilization Committee (TRUC) review does NOT replace Scientific Review (CPRC) or Human Subjects Review (IRB) – but instead is a first assessment of this trial’s fit within the current portfolio of clinical trials prior to the trial moving on to the CPRC.

All Cancer Interventional Therapeutic trials (including pediatric) will be reviewed by the TRUC committee prior to submission to the CPRC. The PI and the MCC Project Manager assigned to the protocol will complete a brief application (see right). Within 1 week of TRUC application submission, the TRUC committee will complete the review and inform the PI of the approval to proceed and prioritization score. The reviewers will confirm with the disease-specific clinical researchers that there is a plan to prioritize patients who may be eligible for related protocols, and the reviewers will provide a priority score for the trial, as required by the NCI. The priority score is based on the MCC strategic goals for clinical trial development and accrual (see link to prioritization score metrics). The committee, comprised of expert clinical trialists and clinical trials office operations leaders will also review the protocol to suggest any potential collaborations, funding opportunities, additional clinical sites (i.e. Southdale, Maple Grove etc.), and to identify any potential issues which could delay approval by the scientific review committee. Protocols with critical flaws or that receive a score that does not meet a minimum threshold for prioritization for resourcing by the MCC will not be approved. Disapproval is expected to be rare, but can be appealed to the Executive CRL, chaired by Masonic Cancer Center Director, Dr. Douglas Yee. Provisional approval may be granted for promising protocols that require additional work (identifying funding etc.). CTO-managed Non-Interventional or Non-Therapeutic Cancer protocols will also be reviewed by this mechanism.

Contact

Contact

Please contact: truc@umn.edu for further information.

      Updates

      June 26, 2018

      PI's are now responsible for submitting the TRUC application.

      TRUC submission deadlines are now twice per month.
      They now align with Cancer Protocol Review Committee deadlines. TRUC approval still must be granted prior to CPRC submission.