Extramural Grant Process

If you are an investigator interested in submitting a grant proposal in collaboration with the PCRC, the following figures outline the ideal steps and timeline to be followed. Embedded in the figures are the supportive and consultative resources available to you as you move through grant/study development and eventually to study start up and implementation.

Pre-Award Phase **Links
** PI should contact the PCRC ideally 4 months prior to grant due date
Letter of Intent
Submit Letter of Intent to PCRC for reviewLetter of Intent Form & Instructions
Contact Core and/or Center Directors for complimentary consultation (up to 3 hours total across all Cores/Centers)PCRC Cores
Collaboration Planning
Work with PCRC Project Coordinating Center (PCC) to determine PCRC Services you wish to useProject Coordinating Center Services Checklist
PCRC creates budget for PI review based on services selectedContact Project Coordinating Center Pre-Award Grant Manager, Tim Oakberg
Site Identification (if applicable)Site Collaboration Checklist
Complete Project Information Form, including per participant payment and start up payment for sites (site budgets)Project Information Form template
PCRC per-participant payment model information sheet
PCRC sends “warm handoff” email to potential study sites with Project Information Form
Study PI directly talks with potential Study Site PIs about study specifics and budget (including Single IRB)
Study PI obtains commitment from sites and requests Letters of Support and other required docs from each site for grant application
Letter of Support
PI provides PCRC-requested Letter of Support languageLetter of Support instructions
PI informs PCRC which Cores/Centers were contacted pre- and post-award

PI Received Fundable ScoreLinks
Protocol Development
Use PCRC Protocol Instructions and templatePCRC Protocol instructions & template
Ensure PCRC-required language is included
Provide to Project Coordinating Center (PCC) for review and comments
Revise protocol as necessary – it is now ready for review by PCRC’s Scientific Review Committee
Data Related
Analysis Plan: Consult with budgeted Data Informatics & Statistics Core (DISC) to review your analysis planData Informatics & Statistics Core (DISC)
Data Dictionary: Consult with budgeted Data Informatics & Statistics Core (DISC) to review your data dictionary and ensure PCRC-required core data elements are includedData Informatics & Statistics Core (DISC)
Data Collection Tools: Consult with Measurement and/or Caregiver Core to review your instrumentsMeasurement Core and Caregiver Core
IRB
Study PI determines and communicates to PCRC which IRB will serve as single IRB of record
Ensure all study sites are SMART IRB membershttp://www.smartirb.org
Study PI team prepares IRB application materials in collaboration with PCRC
Collect necessary information from each study site to include in single IRB application
PCRC maintains regulatory file for study

When Study is FundedLinks
** Responsible party determined during pre-award phase & included in budget
Finalization of Study Protocol
Protocol reviewed by PCRC’s Scientific Review Committee (SRC)
Comments/suggestions from SRC incorporated; protocol revised (if necessary)
Protocol provided to Study Site PIs (SSPIs) for their review (at PI’s discretion)
Protocol finalized by Study PI
Finalized protocol handed over to PCRC to ensure version control
Pre-Implementation Tasks **
Finalize data collection tools, consulting with Cores/Centers as neededPCRC Core contact
Project Coordinating Center Contact list
Finalize data dictionary and build of database, consulting with Data Informatics & Statistics Core (DISC), as appropriateData Informatics & Statistics Core (DISC)
Develop data collection instructions / manual, consulting with Project Coordinating Center and Data Informatics & Statistics Core (DISC) as appropriateProject Coordinating Center Contact list
Submit IRB application to Single IRB of record
Prepare necessary finance/contract paperwork
PI communicates with any Core leaders who are included in the study budget for post-award consulting
Work with Project Coordinating Center to develop Study Start Up training materials

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