PGpR2 Supplement for Continuation of the Scientific Data Research Center (SDRC) of the Gastroparesis Clinical Research Consortium (GpCRC)

项目摘要/摘要 约翰霍普金斯大学的这项提议将继续作为科学数据研究中心 (SDRC)给胃轻瘫临床研究联盟(GpCRC)，由美国国立卫生研究院赞助 自2006年以来，支持儿科临床中心继续收集数据和生物标本 为8-24岁有胃瘫症状的参与者创建儿科胃瘫登记表2。 国家发改委扩大儿科联合体的目标是：1)开发和开展新的儿科 有胃轻瘫症状的患者的胃轻瘫和功能性消化不良登记；以及2) 协调和实施单一IRB(SIRB)的使用，以监督所有参与的儿科中心。 国家发改委将在生物统计分析、研究设计、数据系统设计方面提供领导和专业知识 和管理、多中心协调、质量保证、项目支持、沟通和 组织，并将负责支持未来的所有议定书开发或修改，包括 提供样本量计算、统计建议、表格开发、数据分析和手稿 准备工作。国家发改委将支持开发、实施、维护和数据监测真实的- 为PGpR2研究准备临床信息的时间数据库，以提交给 供公众使用的NIDDK中央存储库，并维护程序输出和标本的数字存储库 化验或基因组数据。国家发改委将为各委员会准备所有业绩和数据监测报告 包括指导委员会和执行委员会、战略规划和预算编制以及可能出现的特别报告。国家发改委将 准备协议或未来的协议更改以提交给SC、NIDDK计划办公室，以及数据和 安全监测委员会(DSMB)，以及支持调查的法规文件和报告 代表NIDDK的新药(IND)或研究设备豁免(IDE)申请。协同效应 GpCRC研究人员和专家科学家之间使用生物检疫试剂和临床元数据的伙伴关系 为了促进对胃轻瘫发病和进展的决定因素的了解，将 由国家发改委支持。国家发改委将与临床中心合作，协调 临床中心生物标本的制备、编码和运送至NIDDK中央资料库及工作 与储存库一起管理生物检疫品的接收和库存以及用于 存储在NIDDK中央储存库，并满足调查员样本和数据的要求。国家发改委将 管理GpCRC政策声明、SOP、辅助研究、 演示文稿和出版物。

Project Summary/Abstract This proposal from the Johns Hopkins University is to continue as the Scientific Data Research Center (SDRC) to the Gastroparesis Clinical Research Consortium (GpCRC), sponsored by the National Institutes of Health since 2006, to support the pediatric clinical centers as they continue to collect data and biospecimens for participants ages 8-24 with symptoms of gastroparesis to create a Pediatric Gastroparesis Registry 2. The SDRC aims for the expansion of the Pediatric consortium are: 1) To develop and conduct a new pediatric gastroparesis and functional dyspepsia registry of patients with symptoms of gastroparesis; and 2) To coordinate and implement use of a single IRB (sIRB) to oversee all participating pediatric centers. The SDRC will provide leadership, expertise in biostatistical analysis, study design, data system design and management, multicenter coordination, quality assurance, project support, communication and organization, and will be responsible for supporting all future protocol development or modifications, including providing sample size calculations, statistical advice, forms development, data analysis and manuscript preparation. The SDRC will support development, implementation, maintenance, and data monitoring of a real- time database of clinical information for the PGpR2 study, prepare de-identified databases to submit to the NIDDK Central Repository for public-use and maintain a digital repository of procedure output and specimen assay or genomic data. The SDRC will prepare all performance and data monitoring reports for committees including the Steering and Executive Committees, DSMB, and ad hoc reports that may arise. The SDRC will prepare protocols or future protocol changes for submission to the SC, NIDDK program office, and Data and Safety Monitoring Board (DSMB), along with regulatory documents and reports in support of Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications on behalf of the NIDDK. Synergistic partnerships between GpCRC investigators and expert scientists to use biospecimens, and clinical meta-data to advance the understanding of the determinants of the pathogenesis and progression of gastroparesis will be supported by the SDRC. The SDRC will collaborate with the clinical centers to coordinate procedures for preparation, coding, and shipping of clinical center biospecimens to the NIDDK Central Repository and work with the Repository to manage the receipt and inventory of biospecimens and de-identified Public-Use data for storage in the NIDDK Central Repository and fulfilling investigator specimen and data requests. The SDRC will manage the development, approval, and amendments of GpCRC policy statements, SOPs, ancillary studies, presentations, and publications.