Investigator Initiated Multi-Site Clinical Trials (R01)

-Purpose. The purpose of this Funding Opportunity Announcement is to provide a vehicle for submitting grant applications for investigator-initiated multi-site Phase II or Phase III randomized, controlled clinical trials. The trials may address any research question related to the mission and goals of NHLBI and may test clinical or behavioral interventions. Investigators should consult the NHLBI s Guidelines for Investigator Initiated Clinical Trials (http://www.nhlbi.nih.gov/funding/policies/clinical.htm) for more detailed instructions and information about multi-site clinical trial grant applications. Additional information about the mission, strategic plan and research interests of the NHLBI can be found at NHLBI s website (http://www.nhlbi.nih.gov/index.htm). -This Funding Opportunity Announcement is not intended for support of single-center studies or multi-center observational studies that are not testing an intervention. -Mechanism of Support. This FOA will utilize the NIH Research Project Grant (R01) award mechanism. Awards may be converted by NHLBI to cooperative agreements (U01).