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 |
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** PI should contact the PCRC ideally 3 to 4 months prior to grant due date for the Letter of Intent (scientific review) process |
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| Letter of Intent | |
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Complete Letter of Intent (using template) |
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Complete the PCRC Project Coordinating Center (PCC) Services checklist, selecting the PCRC Services you wish to use / learn more about |
PCC Services Checklist |
| Complete a study schema to include as an attachment with your Letter of Intent (also reviewed by SRC) | Study Schema template |
| Submit LOI and related attachments by completing this on-line request form | On-line Submission Portal |
| Contact Core and/or Center Directors for complimentary consultation. | PCRC Cores |
| Collaborations Involving Budget/Subcontract with PCRC | |
| The PCRC will create a budget based upon the PCC checklist responses | Request meeting to discuss scope of work and budget for proposed work |
| 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 requesting a Letter of Support should submit request using the on-line submission portal. For LOS requests, please give 2-3 weeks lead time. | Letter of Support Request: On-Line Submission Portal |
| PI informs PCRC which Cores/Centers were contacted pre- and post-award |
| PI Received Fundable Score | Links |
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| Protocol Development | |
| Use PCRC Protocol Instructions and template | PCRC 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 plan | Data Informatics & Statistics Core (DISC) |
| Data Dictionary: Consult with budgeted Data Informatics & Statistics Core (DISC) to review your data dictionary and ensure PCRC-required standardized data elements are included | Data Informatics & Statistics Core (DISC) |
| Data Collection Tools: Consult with Measurement and/or Caregiver Core to review your instruments | Measurement 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 members | http://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 Funded | Links |
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| 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 needed | |
| Finalize data dictionary and build of database, consulting with Data Informatics & Statistics Core (DISC), as appropriate | Data Informatics & Statistics Core (DISC) |
| Develop data collection instructions / manual, consulting with Project Coordinating Center and Data Informatics & Statistics Core (DISC) as appropriate | Project 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 (if included in budget) | |
| ** Responsible party determined during pre-award phase & included in budget |