Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)

This Funding Opportunity Announcement (FOA) supports applications for a collaborating Data Coordinating Center (DCC) investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. Trials for which this FOA applies must be relevant to the research mission of the NHLBI and meet the definition of an NIH clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website. This FOA will utilize a cooperative agreement mechanism of award and runs in parallel with a companion FOA (PAR-19-NNN) that encourages applications for a collaborating Clinical Coordinating Center (CCC). The DCC application must be specific for the clinical trial being proposed in the collaborating CCC. The objective of the DCC application is to present a comprehensive plan to provide overall project coordination, administration, data management, and biostatistical support for the proposed clinical trial. Both a DCC application and a collaborating CCC application must be submitted on the same application due date for consideration by NHLBI. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this FOA.