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