?DATA MANAGEMENT AND REPORTING GROUP High-quality clinical data management has been a cornerstone of Rho services since its inception. Over the last 2 decades, Rho has served as the coordinating center for numerous NIH-sponsored observational studies and clinical trials, which has given us extensive experience developing, implementing, and maintaining innovative and reliable data systems for clinical research. In anticipation of the consolidation of study coordination activities across DAIT consortia, Rho has worked over the last year to standardize methods and processes across our current consortia. The Data Management and Reporting Group Component will provide?across the 3 disease groups? high-quality, integrated, and secure information management systems and well-developed procedures for the collection of clinical and mechanistic data, the randomization of study subjects, the tracking of specimen collection and distribution, and the reporting of safety data. New DAIT studies coordinated by the Center will use the following systems for data management and reporting: ? Medidata Rave (an industry-leading, state-of-the-art, web-based data management tool) for the receipt, entry, verification, processing, correcting, storage, tracking, transmission and reporting on all clinical data and clinical laboratory data. Medidata Rave minimizes routine data entry errors and boosts efficiency through robust data validation functionality that effectively turns data capture and data cleaning into 1 process. ? RhoRAND? for 24-7 access to participant registration and randomization using web-based or interactive voice response technology. Non-computerized methods will be available if needed. ? Oracle Argus safety data system for entering, tracking, coding, reporting, analyzing, and archiving SAE data for clinical studies in accordance with federal and international regulations. Rho will carefully and comprehensively monitor accruing study data for enrollment status, visit and procedure completion status, and safety triggers. RhoPortal will be used across the DAIT Consortia to provide near real-time access to information about study progress. Any data quality or study progress metric that the Consortia Investigators or DAIT personnel wish to see routinely can be made available via RhoPortal. We will use the CDISC CDASH standard for clinical data management for new studies managed by the Center. CDASH provides a study with a library of data elements that are also an industry standard and is an excellent starting point for efficiently setting up a clinical data management system. Rho has already begun the process of developing standards for forms and variables that do not exist in CDASH, but which are common across our studies and therapeutic areas. This ?RhoDASH? global library will grow organically over time, and will allow us to store final study data in a standard format that can be uploaded to data sharing portals.
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