Cardiovascular disease is the leading cause of death in the United States, accounting for over one quarter of all deaths every year. Some medical products intended to treat cardiovascular disease and other diseases have significant and potentially dangerous side effects related to their effects on the heart.

Moreover, cardiac safety concerns are a leading cause for the recall of marketed drugs and abandonment of drug development programs for any indication.

The Cardiac Safety Research Consortium (CSRC) was launched in 2006 through an FDA Critical Path Initiative Memorandum of Understanding with Duke University to support research into the evaluation of cardiac safety of medical products.