DE PEDIATRIC COBRE: CLINICAL RESEARCH SERVICES CORE

DE PEDIATRIC COBRE：临床研究服务核心

• 批准号: 8360758
• 负责人: Judith L Ross
• 金额: $ 11.83万
• 依托单位: ALFRED I. DU PONT HOSP FOR CHILDREN
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8360758
• 关键词: Basic Science; Centers of Research Excellence; Childhood; Clinical Pharmacology; Clinical Research; Clinical Trials; Consent; Data Base Management; Ensure; Funding; Grant; Human Subject Research; Institutional Review Boards; National Center for Research Resources; Pediatric Research; Principal Investigator; Research; Research Design; Research Infrastructure; Research Personnel; Resources; Services; Source; Training; Translational Research; United States National Institutes of Health; Work; cost; human subject; meetings; programs; protocol development; research study

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. 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 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.

这个子项目是利用资源的许多研究子项目之一。 由NIH/NCRR资助的中心拨款提供。对子项目的主要支持 子项目的首席调查员可能是由其他来源提供的， 包括美国国立卫生研究院的其他来源。为子项目列出的总成本可能 表示该子项目使用的中心基础设施的估计数量， 不是由NCRR赠款提供给次级项目或次级项目工作人员的直接资金。 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。