The PAC3 Scientific Review Committee (SRC) and Data Coordinating Center (DCC) are committed to improving the efficiency of the research proposal submission process. Our goal is to align the required expertise and resources with the SRC and DCC at the earliest phase of each proposal to determine feasibility, improve efficiency, and increase the impact of each proposal. Based on prior experience, our future goals and objectives are:
- To provide feedback to investigators earlier in the proposal process so that both research questions and data analytics expectations are clearer with a goal to streamline back-and-forth conversations between the investigator team and DCC.
- To help the SRC and DCC organize projects with a cadence that will be more productive and minimize the crush that currently often occurs leading up to some of the most frequently attended meetings.
To this end, we are initiating a new first step to the process, the Research Intent Letter (RIL). The RIL is a one-page outline submitted by the investigator team with the following information:
- Principal Investigator (PI)
- PI Institution
- Co-Investigators’ Name & Institution (minimum of 3 participating institutions)
- Title
- Date of submission
- Specific Aims
- Primary aim, hypothesis, and primary outcome to be measured
- Overall goal
- Outcome(s) to be measured to achieve this goal
- Brief description of expected covariates/dependent variables to be used in analysis
- Study population (inclusion and exclusion criteria)
- Impact
- What gap in knowledge does the project address?
- What is the short and long-term impact of this proposal?
The RIL is not intended to replace the Minor Data Request process. A Minor Data Request may be submitted to provide the investigator an understanding of whether the registry has sufficient data for a RIL and research proposal. These processes may occur together.
The investigator should complete a copy of the Research Intent Letter template and submit it to pac3@childrens.com.
Proposed timeline for proposal process:
- A call for RIL’s will occur biannually with a deadline for submission in early February and early November. The current deadline for submission for an RIL is November 1, 2024. Any RIL submitted after that date will be considered for the next submission deadline.
- A response will be provided by the SRC to the Principal Investigator within 4 weeks of submission.
- An RIL that receives a favorable review will be expected to result in a research proposal submitted to the SRC for review within 2 months from the RIL decision letter.
We look forward to collaborating with your sites and investigator teams.
Sincerely,
Ronn E. Tanel, MD
Chair, PAC3 Scientific Review Committee
Chitra Ravishankar, MD
Chair, PAC3 Scientific Review Committee
Sonali Patel, MD, PhD
Chair, PAC3 Data Coordinating Center