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University of Colorado Cancer Center

University of Colorado Cancer Center, A National Cancer Institute-designated Comprehensive Cancer Center
 

Protocol-Specific Review Process

Protocol-Specific Research is a procedure for prioritizing and selecting unfunded or underfunded PI-initiated studies for coordinator support. All unfunded investigator-initiated intervention studies will be directed into this process, including externally (such as unfunded CTEP-approved protocols) and internally peer-reviewed studies.

Maximum Request: $10,000

PIs may request a maximum $10,000 for regulatory and study coordinator time and effort. Do not request funding for study-related testing, PI funds or ICR/overhead. We encourage you to consult with Donna Wilber to create a draft budget.

Eligibility Criteria

  • Investigator-initiated, novel, innovative, pilot, feasibility, early phase studies
  • Minimal or no funding sources
  • Priority to intervention studies (drug, surgery, XRT, etc.)
  • PI is CU Cancer Center member (full or associate)
  • PI has completed required training (COMIRB 101, 201; CU Denver HIPAA)
  • Exempt and expedited trials are not eligible

    • Submission Format

  • Face page: Title, PIs, CRC
  • Budget estimates (work with CRC for time and effort)
  • Other potential funding
  • Protocol in late draft or final form: 1 hard copy and 1 e-copy 
  • Rationale
  • Background
  • Specific Objectives
  • Endpoints
  • Treatment Plan
  • Eligibility
  • Study Procedures
  • Study Calendar
  • Assessment of Endpoints
  • Statistics
  • Data Safety Monitoring Plan
  • Ethical Considerations
  • References
  • All signed PRMC forms: the CIC Team Leads can help you complete these
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    You must send your submission by email by the deadline to:

    Arthur Liu, MD, PhD,  PRMC Chair, arthur.liu@ucdenver.edu

    Tom Flaig, MD, Medical Director, Thomas.Flaig@ucdenver.edu.

    Be sure to use PSR Submission as your subject line.

    Submission Deadlines

    The third Tuesday of every month.

    What Happens After Submission

  • CU Cancer Center CISR PI Advisory Committee will perform peer review, which will also serve as PRMC peer review. CISR Medical Director Tom Flaig, MD, and PRMC Chair Arthur Liu, MD, PhD are the co-chairs.
  • Each month, the PRMC will solicit CU Cancer Center members electronically, and the committee will review all submitted protocols.
  • Your submission is distributed by email to the PRMC.
  • Two or more reviewers will provide written reviews. The PI will also receive comments at the meeting and priority scores using NIH format.
  • Funding allocations are announced within a week after the committee meets.
  • If your study is not funded, we encourage you to revise your study and resubmit it.

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