Protocol-Specific Review Submission

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 Jen Maitlen or 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 interverntion studies (drug, surgery, XRT, etc.)
• PI is UCCC member (full or associate)
• PI has completed required training (COMIRB 101, 201; UC 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 ecopy 
  • 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

You must send your submission by email by the deadline (see right panel) to:

Gloria Ochoa, PRMC Manager, gloria.ochoa@uchsc.edu

Jen Maitlen, RAC Manager, jennifer.maitlen@uchsc.edu

and copy

Brian Kavanagh, MD, PRMC Chair, brian.kavanagh@uchsc.edu

Madeleine Kane, MD, PhD, Medical Director, madeleine.kane@uchsc.edu

Be sure to use PSR Submission as your subject line.

2008 Submission Deadlines

January 31
March 31
May 31
July 31
September 30
November 30

What Happens After Submission

• UCCC CIC PI Advisory Committee will perform peer review, which will also serve as PRMC peer review. CIC Medical Director Madeleine Kane, MD, PhD, and PRMC Chair Brian Kavanagh, MD, MPH are the co-chairs.
• Each month, the PRMC will solicit UCCC members electronically, and the committee will review all submitted protocols monthly. Submission deadlines are on the right panel of this page: If you received a PSR submission notice in July, your submission deadline is July 31.
• 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 you study is not funded, we encourage you to revise your study and resubmit it.