By Michael Macri and Sherry Merrifield, INC Research/inVentiv Health
Since the U.S. Food & Drug Administration published its guidance on Risk-Based Monitoring approaches to clinical trials, sponsors have demonstrated a mixture of interest in, and trepidation toward, focusing their oversight activities on those areas that present the greatest risk to human safety and data integrity. The methodology is new enough that best practices are still being developed by sponsors and Clinical Research Organizations alike. One clear recommendation that is emerging, however, is to assign the ongoing responsibility of managing a trial’s risk to a new member of the study team: the Clinical Risk Manager. The creation of this dedicated role ensures that trial risks are assessed and mitigated systematically by an expert with the express responsibility and authority to do so. The following paper explains the need for this position, what should be expected of a Clinical Risk Manager, and how the role can operate effectively within the study team.