Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3) - Clinical Trial Required

This Funding Opportunity Announcement (FOA) supports applications to develop and implement a Clinical Coordinating Center for investigator-initiated multi-site clinical trials (Phase II and beyond). Trials for which this FOA applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a 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: http://www.nhlbi.nih.gov. This FOA will utilize a bi-phasic, milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion FOA that encourages applications for a collaborating Data Coordinating Center (PAR-16-301). The objective of the Clinical Coordinating Center application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should include plans for project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. Both a Clinical Coordinating Center (CCC) application and a collaborating Data Coordinating Center (DCC) 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 prior to submitting an application.