July 2009

The improvement of echocardiographic imaging in clinical trials research requires optimal core lab practices but goes beyond these to include all stakeholders in the research process: sponsors, trialists, clinical sites, information technology specialists, statisticians, regulators, and imagers. In this expert consensus document, we have outlined the roles and responsibilities of core labs, their relationships to other components of the trial, and, most important, procedures by which ECLs can optimize results and improve the accuracy and precision of the information they provide to parent studies. This has been shown prospectively to improve the efficiency and quality of clinical research. It is hoped that these best practices are broad enough to be applicable to other forms of cardiovascular imaging, if not all imaging used in clinical trials research.