DE PEDIATRIC COBRE: CLINICAL RESEARCH SERVICES CORE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Clinical Research Services Core will enhance the services that the existing Clinical Pharmacology Program provides for studies involving human research subject. This program currently provides oversight and facilitation of clinical trials; this does not fulfill the needs of the basic and translational research proposed in this Center application. We will expand the services of this core to directly serve the needs of research studies involving human subjects. The core facility will be directed by James Hildebrand, Pharm.D. who has more than 20 years experience in the oversight of clinical trials in both academia and industry. The core will provide trained study coordinators who will assist the target investigators with study design, subject recruitment and database management, as well as facilitate interactions with the IRB by working with the target investigators on protocol development and consent to ensure that they meet institutional and federal requirements.