Gastroparesis Clinical Research Consortium - Data Coordi

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DESCRIPTION (provided by applicant): The Johns Hopkins University Center for Clinical Trials (CCT) proposes to serve as the Data Coordinating Center (DCC) for a Gastroparesis Clinical Research Consortium, which will focus on the etiology, natural history, and therapies for gastroparesis. The DCC will be responsible for organization of the consortium including definition of the committee structure by specifying membership, managing the member selection process, and writing the charges for each committee, subject to consortium approval. The DCC will coordinate all aspects of communications needed by the consortium, including meetings, teleconferences, and web-based communications. The DCC will support the development of consortium policies including policies on presentations, publications, ancillary studies. The DCC will work with the NIDDK and the Steering Committee (SC) to provide the biostatistical and informations systems infrastructure to rapidly and efficiently design and conduct multicenter randomized clinical trials of potential treatments for gastroparesis. The DCC will cull information from the literature or other sources for data on standardized outcome measures needed to make sample size determinations for each proposed study. The DCC will take the initiative in the implementation, conduct, and quality control of consortium studies. The DCC will provide biostatistical analysis for data safety and monitoring reports and for presentations and publications for consortium studies. Building on systems used by ongoing research networks coordinated by the CCT, the DCC will provide a comprehensive information management system including the development and distribution of design documents (protocols, manuals, case report forms, policy memoranda, etc), a study website for up-to-date access to study-related materials, and a web-based data management system (for screening and enrollment of patients including randomization procedures for clinical trials, for data capture and display, for reporting on recruitment, and for quality control reports to improve clinical center performance). The DCC will provide other support, as needed, including the establishment of centralized laboratories, reading centers, drug distribution center, or specimen banking resources. The DCC has extensive experience with the FDA/IND process and can assist the consortium in these matters, as required. IRB and HIPAA compliance for the consortium will be monitored by the DCC