RhoFED CDSMC - PROJECT SUMMARY/ABSTRACT The NIAID Clinical Data and Safety Management Center (CDSMC) is a consolidated clinical support service center conceived to manage NIAID’s portfolio of clinical research in allergic diseases, asthma, autoimmune disorders, and immune-mediated complications of transplant, continuing programs supported by Rho under prior awards. Our vision is to advance NIAID’s history of successful clinical research by continuing our successful collaboration in data management, safety, and specimen tracking with a focus on continuity while embracing innovation. Over the last two decades, innovation has dramatically changed clinical trial operations, with the technology revolution advancing trial data systems and advances in biology enabling research to halt disease processes. The Rho team seeks to continue our support of NIAID’s work to deliver on this promise. Rho has served as a clinical data, safety event, and biospecimen tracking center since its founding. Rho has guided NIAID from the age of paper and FAX submissions through the introduction of computer data systems and into the era of Software as a Service (“SaaS”) hosting of critical research systems. Over this time, Rho has always focused on gradual evolution of systems to ensure that NIAID-supported research has access to the current best practices in study management while avoiding the risks of too early adoption. We propose to provide services by organizing the CDSMC into four cores: an Administrative Management Core (AMC) that will be led by the Principal Investigator from a scientific perspective and the Program Director from an operations perspective. The AMC will oversee the CDSMC; manage operational, quality, and regulatory compliance reporting to NIAID; and coordinate DSMB support with NIAID and other functional work areas. The Data Management Core (DMC) will provide strategic and operational support for data collection, management, and processing; support the Rave EDC (Medidata, Inc. New York, NY); develop eCRFs and build study databases; and manage data quality and the study data lifecycle. The Safety and Pharmacovigilance Center (SPC) will receive, process, analyze, and report adverse events and provide comprehensive pharmacovigilance support to NIAID-supported clinical trials. The SPC will provide support for addressing safety and pharmacovigilance during study design and manage query generation and resolution, narrative generation, summary reporting, and unblinding. The Specimen Tracking Core (STC) will inform considerations of specimen handling and tracking during study design and will support tracking and reporting during studies, leveraging our experience developing the specimen tracking strategy currently used in NIAID DAIT studies. Based on our long history of supporting NIAID-funded clinical research and our experience incorporating innovation into clinical research to deliver improvement and avoid risk, we believe we can effectively support the achievement of NIAID’s research goals.
