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

项目总结/摘要 这个来自约翰霍普金斯大学的建议是继续作为科学数据研究中心 （SDRC）向胃轻瘫临床研究联盟（GpCRC）提交了一份由美国国立卫生研究院（National Institutes of Medicine）赞助的研究报告。 自2006年以来，支持儿科临床中心继续收集数据和生物标本 为年龄8-24岁有胃轻瘫症状的参与者创建儿科胃轻瘫登记2。的 SDRC扩大儿科联盟的目标是：1）开发和开展新的儿科 具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） 协调并实施使用单一IRB（sIRB）来监督所有参与的儿科中心。 SDRC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 管理、多中心协调、质量保证、项目支持、沟通和 组织，并将负责支持所有未来的方案开发或修改，包括 提供样本量计算、统计建议、表格编制、数据分析和手稿 准备. SDRC将支持真实的- PGpR 2研究临床信息的时间数据库，准备去识别数据库提交给 NIDDK中央存储库供公众使用，并维护程序输出和标本的数字存储库 分析或基因组数据。SDRC将为委员会准备所有性能和数据监测报告 包括指导委员会和执行委员会、DSMB以及可能出现的特别报告。SDRC将 准备方案或将来的方案变更，以提交给SC、NIDDK项目办公室和数据，以及 安全性监查委员会（DSMB），沿着支持研究的监管文件和报告 代表NIDDK申请新药（IND）或试验用器械豁免（IDE）。协同 GpCRC研究者和专家科学家之间的伙伴关系，以使用生物标本和临床元数据 为了进一步了解胃轻瘫的发病机制和进展的决定因素， 由SDRC支持。SDRC将与临床中心合作， 临床中心生物标本的制备、编码和运输至NIDDK中央储存库， 与储存库一起管理生物标本和去识别公共使用数据的接收和库存， 储存在NIDDK中央储存库中，并满足研究者的标本和数据要求。SDRC将 管理GpCRC政策声明、SOP、辅助研究的制定、批准和修订， 演讲和出版物。

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.