Single Source: Cardiothoracic Surgical Trials Network (CTSN) Data Coordinating Center (U01 Clinical Trial Required)

This is a Notice of Funding Opportunity (NOFO) for a Single Source that will invite an application from the eligible organization to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application will be peer-reviewed, and if it is not a meritorious application, it will not be funded. This single source NOFO is intended to support a Data Coordinating Center (DCC) to conduct the activities of the Cardiothoracic Surgical Trials Network (CTSN). The DCC will consist of two collaborating components including a Data Management and Analytics Center (DMAC) and a Clinical Coordination Center (CCC). NHLBI strongly encourages multi-PD/PI applications with two PDs/PIs; one PD/PI for the DMAC and one PD/PI for the CCC. The primary responsibility of the DCC is to oversee the conduct of multiple randomized clinical trials in the CTSN.The DCC will support regulatory and administrative activities, data collection and management, and statistical analysis and reporting of trial results in a timely manner. The DCC will promote collaboration and communication among CTSN investigators and the broader research community and will coordinate outreach activities including engaging foundations, research entities, and small businesses in trials of mutual interest and public health importance. The DCC is responsible for integrating the efforts of clinical sites, core laboratories, and other collaborators, and conducting long-term follow-up centrally via telephone follow-up at the DCC. The NHLBI anticipates that the DCC will manage a Clinical and Implementation Research Skills Program centrally. The clinical and implementation research scholars program will support the expanded integration of clinical skills with dissemination and implementation science scholarship to enhance implementation research capacity. The scholars program would be designed to foster additional research questions within CTSN as well as generate a cohort of researchers who would transport their scholarship as they transition to leadership positions in academic and clinical programs.