Site culture is a significant, yet under-addressed factor on the impact of timely and complete adverse event (AE) reporting; a large component of patient safety and execution of quality clinical trials. AE collecting, documenting and reporting seems straightforward process that can be covered with a standard operating procedure. In reality, the process itself is impacted by the site culture and effective communication among all of the employees at the site. Quality sites also have a culture that recognizes that clinical trials and their participants are complex, thus requiring checks and balances between the team. This presentation will define the negative impact of strained site cultures on adverse event reporting, identify internal and external pressures, and strategies for improving culture, communication, and adverse event reporting.
Molly Downhour, MHA, BSN, NEA-BC, OCN, CCRC, Strategy Executive, Medix
Dr. John Nocero, PhD, MBA, CCRP, GCP, ACB, CC, Research Program Leader, Duke Office of Clinical Research