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

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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.