1 THRASHER RESEARCH FUND CONCEPT PAPER

(Instructions are written in italics and should be deleted prior to submission. Send completed form as an email attachment to MartinezAF@ThrasherResearch.org) Title: (limit to 100 characters, including spaces) Principal Investigator: (include degrees) Information for Principal Investigator Academic Position/Title: Phone: Email: Website: (if applicable) Mailing Address: Co-Principal Investigators: (include degrees) Length of Study: (Maximum 3 years) Estimated Total Budget: (Does not need to be itemized) Supervising Institution: Project Site(s):

The Scientific Summary should be limited to one page using 11 point Calibri or Arial font and .75 inch margins all around. References are not required or expected. If the applicant feels that a reference is necessary, it should be included within the one page limit, either embedded in the text or inserted at the bottom. Background: Give a brief general overview of the significance of the problem to childrens health. Estimate the incidence/prevalence of the problem, being specific to the sub-population that might benefit from the research. Include a brief evaluation of previous research, existing knowledge or clinical practice, and include any additional background information indicating the rationale for the proposed research. Specifically identify the research gap(s) the project is intended to address. Include any preliminary data that may support the hypotheses. Hypothesis(es) and Aims: State each hypothesis in a single sentence. Briefly describe the related aims. Design: Describe how the study will be carried out. Specifically State the design of the study (e.g. randomized controlled trial, case-control, prospective cohort, cross sectional etc). As applicable, include the following information (can be in paragraph form rather than a numbered list): 1. Study subjects, including major inclusion/exclusion criteria 2. Sample size and resulting power(if there is not a calculated sample size, state this and justify) 3. Other sample material to be used in the study 4. State the primary outcomes and how they will be measured Potential Impact: Discuss where the research is leading, in what ways and in how many years the findings might potentially influence the prevention, diagnosis and/or treatment of the particular medical problem in children.

SCIENTIFIC SUMMARY

Limit each response to a single sentence unless otherwise noted. The purpose of the Structured Lay Summary is to consolidate key elements of the Scientific Summary in an easily referenced list. It is acceptable to copy and paste relevant information directly from the Scientific Summary, although if the description is technical, the language can be simplified in this summary for scientifically educated readers who may not have expertise in the particular topical area. Describe the medical problem as it relates to children State the incidence/prevalence of problem in children Background that will lead to the research gap (may use 2 sentences) State the primary research gap this study will address Hypotheses (one sentence per hypothesis) Specific Aims (one sentence per aim, maximum 3 for the lay summary) Study design Describe study population or sample material Sample size/power of primary endpoint Assuming the project is successful, state the next step moving down the pathway to clinical applicability

STRUCTURED LAY SUMMARY