RhoFED T-SCCC

Rho Federal Systems Division, Inc., Chapel Hill NC

Investigators

Abstract

PROJECT SUMMARY/ABSTRACT Through this Funding Opportunity Announcement, NIAID is establishing a Transplantation Statistical and Clinical Coordinating Center (T-SCCC) to provide statistical design and analysis, study management, and biospecimen support services for transplant studies funded through NIAID-supported research networks, including ITN, CTOT, and CTOT-CA. As the current NIAID Division of Allergy, Immunology and Transplantation Statistical and Clinical Coordinating Center (DAIT SACCC) providing statistical design and analysis, study management, and biospecimen support, as well as data management, safety surveillance support, and clinical monitoring services for transplant studies, Rho is uniquely well-suited to serve as the T-SCCC. Our objective is to provide excellent service for all activities required per the T-SCCC RFA and to collaborate with NIAID leadership and staff and other NIAID-supported service centers to facilitate efficient provision of all clinical support services for all transplant studies across all the research consortia. To accomplish this objective, Rho will (1) provide leadership and staff with experience in organ transplantation research and the administrative infrastructure needed to manage resources efficiently, to resolve technical and operational issues, and to facilitate effective interaction and collaboration within and between the T-SCCC, investigators, DAIT colleagues, other DAIT-supported service centers, consortia leadership, oversight boards, and regulatory agencies; (2) provide advanced expertise in biostatistics for the efficient design and analysis of observational, interventional, and mechanistic studies in organ transplantation, including analysis of clinical and mechanistic data, preparation of statistical analysis plans in collaboration with investigators and NIAID personnel, and preparation of study reports, presentations, and manuscripts; (3) provide scientific and operational leadership as well as technical and administrative support to enhance communication among study management team members, enable efficient development of protocols and protocol-related documents, expedite study initiation through skillful synchronization of initiation activities, manage oversight of study implementation at the sites, and aid in ensuring proper study conduct and collection of high-quality data; (4) provide experienced staff to determine study needs for biospecimen collection, processing, and shipping; to design study- and visit-specific biospecimen kits as needed; to arrange for procurement of supplies either in bulk or via a web-based supply management system for ordering kits; and to train clinical site personnel on the use of the web-based supply management system; and (5) provide state-of-the-art web-based management systems for tracking the collection, handling, labeling, shipping, storage, disposal, and reporting of biological samples and for the reconciliation of data results corresponding to biological samples and experienced staff to train clinical personnel on the collection and handling of samples and the use of the web-based systems.