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

This funding opportunity announcement supports applications for a collaborating Data Coordinating Center (DCC) for investigator-initiated multi-site clinical trials. The trials may include efficacy, comparative effectiveness, pragmatic, and/or implementation research clinical trials. The DCC will provide overall project coordination, administration, data management, and biostatistical support for the clinical trial proposed in the collaborating Clinical Coordinating Center (CCC) application. • The DCC application must be submitted on the same application due date as the collaborating CCC application. • The objective of the DCC application is to present a comprehensive plan for the clinical trial. • The FOA utilizes a cooperative agreement mechanism of award and runs in parallel with a companion FOA that encourages applications for a collaborating Clinical Coordinating Center (CCC). • The trials must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial.