DE PEDIATRIC COBRE: CLINICAL RESEARCH SERVICES CORE

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。临床研究服务核心将加强现有临床药理学计划为涉及人体研究课题的研究提供的服务。该计划目前提供临床试验的监督和促进；这不能满足本中心申请中提出的基础研究和转化研究的需要。我们会扩大这个中心的服务，直接为涉及人类受试者的研究提供服务。核心设施将由詹姆斯·希尔德布兰德博士负责。他在学术界和工业界的临床试验监督方面有20多年的经验。核心将提供训练有素的研究协调员，他们将协助目标研究者进行研究设计、受试者招募和数据库管理，并通过与目标研究者合作制定方案和同意来促进与IRB的互动，以确保他们符合机构和联邦的要求。

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.