Frequently Asked Questions for the RFA-HL-10-007: Prematurity and Respiratory Outcomes Program (PROP) (U01)

Q: Does the Clinical Research Center (CRC) application require both a neonatologist and a pediatric pulmonologist?
A: No, but an application may have both. The application does require at least one clinician scientist and one or more scientists with expertise in cutting-edge technology (such as bioengineering, molecular genetics, or imaging).

Q:  What if the CRC doesn't have prior experience with recruiting infants into clinical studies?
A:  Feasibility of recruitment into the study proposed is a review consideration, and will be considered in making funding decisions.

Q:  Does the CRC application have to propose a biomarker in addition to the main hypothesis of a mechanism to predict respiratory outcomes?
A:  Yes, the application must have both a hypothesis and a biomarker proposed.

Q: Should we include in the budget a proposal for the multicenter collaborations?
A: No, a budget will not be necessary to propose in the CRC application for the multicenter biomarker study.

Project Officer:

Carol J. Blaisdell, M.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Bethesda, MD 20892-7952
Telephone: (301) 435-0222

Last updated: January 16, 2009

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