DE PEDIATRIC COBRE: CLINICAL RESEARCH SERVICES CORE

DE PEDIATRIC COBRE：临床研究服务核心

• 批准号: 7382169
• 负责人: Hunter Reeve Underhill
• 金额: $ 9.06万
• 依托单位: ALFRED I. DU PONT HOSP FOR CHILDREN
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-01 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7382169
• 关键词: DE; PEDIATRIC; COBRE; CLINICAL; RESEARCH

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。临床研究服务核心将增强现有的临床药理学计划为涉及人类研究主题的研究提供的服务。该计划目前提供对临床试验的监督和促进；这无法满足该中心应用中提出的基本和翻译研究的需求。我们将扩大该核心的服务，直接满足涉及人类受试者的研究的需求。核心设施将由詹姆斯·希尔德布兰德（James Hildebrand）执导。在学术界和行业的临床试验监督方面拥有20多年的经验。核心将提供训练有素的研究协调员，他们将通过与目标调查人员在协议开发方面合作并同意确保满足机构和联邦要求，从而帮助目标研究人员进行研究设计，主题招聘和数据库管理，并促进与IRB的互动。