How can I collaborate with the PCRC?
The PCRC was established in large part to help overcome the many challenges of multi-site research because we know this research matters, and is necessary to advance the field of palliative care. There are many potential opportunities for collaboration, including:
-
Scientific Review / Guidance
- Research Development
- PCRC Sites
- PCRC Standardized Data elements [SDEs]
- PCRC-recommended instruments
- Data sharing / Registry Participation
- Investigator Development
- Mentoring / Networking opportunities
- Data Quality Assurance Audits
- Statistical consulting
- Caregiver Core
- Measurement Core
- Clinical Studies Core
- Data / Informatics
- Database development / Data Management
- Site Training
- Site Management
- Site Finance
- Grant opportunities
Step 1: Request PCRC Scientific Review Committee (SRC)
Interested investigators must first complete an SRC Review Request Form for an initial review.
Step 2: Approval of the Proposed Research
Approval of the proposed research by the PCRC Steering Committee
Step 3: Study Site PI/Site Selection
- FOA may require a Letter Of Support (LOS) from planned sites – check your FOA
- PCRC will facilitate identification of pertinent collaborators at sites appropriate for the proposed science
- After grant funding, if PI’s selected Study Site PI/ sites are not available, PCRC will assist in identifying additional members who may serve as a Study Site PI
- Number of clinical sites required for enrollment needs is determined by the Statistical Analysis Plan and budget plan
- PCRC will review Membership Database for potential subject population, Study Site PI expertise and site capabiliites
- PCRC will connect PI with potential Study Site PIs
- PI will discuss study with Study Site PIs and obtain site LOS
Step 4: Budget Development (after SRC approval)
Following approval of the proposed research by the PCRC Scientific Review and Steering Committees, the PCRC will work with the Principal Investigator to develop a budget related to PCRC collaboration activities.
- Potential components of PCRC Budget are based on information provided by PI, and include things such as the research plan, 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 subcontract
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 request for SRC review application
- PCRC documents these commitments in LOS
NOTE: pre-grant submission consultation with PCRC Core resources does NOT require a budget – supported by PCRC U2C
Directs/Indirects
Check your Funding Opportunity Announcement (FOA):
- If maximum budget total amounts include only “Direct” costs, Direct Costs include the PCRC subcontract subagreement costs
Budget Example
Step 5: Grant Submission
Following budget approval, the PCRC will provide all grant package documents based upon details in the information provided by the PI. This will include the following:
- Subcontract Package with the 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”