Collaborating with PCRC

Interested investigators must first submit a letter of intent to the PCRC Scientific Review Committee using the PCRC Letter of Intent (LOI) form. Once both the PCRC Scientific Review Committee and Steering Committee approve a LOI, full protocol development will begin. Details around the process and steps are noted below.

• For the PCRC, the LOI means you have a study idea that you think would align well with the PCRC, benefit from multi-site infrastructure, and are planning to submit a grant (click here for more information on grants).
• Submission of the LOI is a pivotal step for the PCRC because it gives the SRC a comprehensive understanding of your study in order to evaluate the science, and enough information to allow the Steering Committee to evaluate the study in light of the strategic goals of the PCRC.
• Approval of the LOI at the Steering Committee level ultimately influences whether the PCRC is able to provide a letter of support stating that it has the necessary infrastructure to successfully implement your study and start budget development (if requested)

Download and complete the Letter of Intent and submit to:

• Rachael Kendrick
• Molly Gavigan RN JD

Approval of the LOI at the PCRC Steering Committee

• FOA may require a Letter Of Support (LOS) from planned sites – check your FOA
• PCRC will facilitate identification of pertinent study sites
• After grant funding, if PI’s selected sites are not available, PCRC will assist in identifying additional sites
• Number of sites required for enrollment needs determined by the Statistical Analysis Plan and budget plan
• PCRC will review Membership Database for potential subject population, study site PI and Site expertise
• PCRC will connect PI with potential sites and study site PIs
• PI will discuss study with study site PIs and obtain site LOS

Following approval of the LOI by the PCRC Scientific Review and Steering Committees, the PCRC will work with the Principal Investigator to develop a budget related to collaboration activities.

• Potential components of PCRC Budget are based on LOI, study schema and details of planned use of PCRC resources
• The components of the budget are dependent upon the specifics in the LOI, study schema and details of planned use of PCRC resources
• Once the budget is approved, the PCRC will create /provide all necessary grant package documents for PCRC sub- contract

Potential Budget Components

Site Payment budget on a per ”participant” model - e.g. start up fees, study conduct, patient remuneration, etc.

• Project Coordinating Center [PCC] Activities
  • Research development
  • Site management (training, support, communications, enrollment tracking, etc.)
  • Site Visits
  • Site finance / grant management (contracts, invoicing, payments, etc.)
  • Database / data management development /informatics

Assistance with DSM committees/boards Packet will include budget justification for PCRC components

Include in PI grant budget

Include applicable PCRC consulting activities to be using during conduct of the funded study in PI’s budget; for example: Statistics, Caregiver, Measurement, and Clinical Studies.

• PI provides details regarding planned PCRC collaborations in the LOI
• PCRC documents commitments in LOS

Directs/Indirects

Check your Funding Opportunity Announcement (FOA):

• If maximum budget total amounts include only “Direct” costs, Direct Costs include the PCRC sub-contract sub-agreement costs

Budget Example

Following budget approval, the PCRC will provide all grant package documents based upon details in the Letter of Intent and planned use of PCRC resources.  This will include the following:

• Subcontract Package with University of Colorado (PCRC primary grant institution)
  • Scope of Work / Biosketch(s)
  • Budget / Budget justifications for the Project Coordinating Center activities
  • Budget / Budget justifications for Planned consortium [genralized for total number of sites and planned accrual]
  • Grant documents [Checklist, FCOI, Tax ID, Face page, etc.]
• Biosketch(s) of PCRC Co-Chair and other relevant
  PCRC key personnel (e.g. Caregiver Core Director) if
  applicable
• Letter of Support signed by the PCRC Executive
  Leadership outlining your specific planned PCRC
  collaboration.*

*Critical to NIH reviewers to demonstrate “collaboration”