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

This is a call for applications for the establishment of a Clinical Coordinating Center (CCC) for carrying out investigator-initiated, multi-site clinical trials. The application should pertain to the research mission of the National Heart, Lung, and Blood Institute (NHLBI) in such areas as efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials according to the NIH (National Institutes of Health) definition of a clinical trial. For more details on the NHLBI's mission and research priorities, applicants can check out the NHLBI website.

This grant opportunity, publicized with the title "Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)", will adopt a two-phase cooperative agreement award method. The process is programed alongside an accompanying Funding Opportunity Announcement (FOA) for the implementation of a collaboratively working Data Coordinating Center (DCC).

As part of the conditions for the grant, applicants are expected to submit a Comprehensive Scientific and Operational Plan as part of the CCC application. It should provide scientific justification for the clinical trial and outline its structure, project management methods, participant recruitment and retention strategies, performance milestones, methodologies for carrying out the trial, and plans for result dissemination.

Of note is that any application for the CCC must be done in conjunction with a DCC application and both must be submitted concurrently on the specified deadline for consideration by the NHLBI. Those interested in making an application are highly advised to reach out to the correct Scientific/Research contact prior to submission.