DE PEDIATRIC COBRE: CLINICAL RESEARCH SERVICES CORE

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。临床研究服务核心将加强现有临床药理学计划为涉及人类研究对象的研究提供的服务。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性研究的需要。我们将扩展这一核心的服务，以直接满足涉及人体对象的研究研究的需要。核心设施将由詹姆斯·希尔德布兰德药学博士领导，他在监督学术界和产业界的临床试验方面拥有20多年的经验。核心将提供训练有素的研究协调员，他们将协助目标调查人员进行研究设计、受试者招聘和数据库管理，并通过与目标调查人员就方案制定和同意进行合作，促进与IRB的互动，以确保他们符合机构和联邦要求。

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.