SSS Quality Management Office Director Speaks at 2017 ACRP Meeting & Expo

Lysa Triantafillou, SSS’ director of Regulatory and Quality Management Systems, spoke at the 2017 Association of Clinical Research Professionals (ACRP) Meeting & Expo in Seattle, Washington. She presented her new session “The Seismic Shift in the Monitoring Paradigm: From Quality Control to Quality Assurance,” to approximately 325 clinical monitors, project managers, clinical investigators, and trial-site support staff eager to understand a practical approach to risk-based monitoring, as well as how to maximize their monitoring resources to have the greatest impact on quality and compliance. She discussed the shift in the monitoring paradigm from the quality control approach of checking each data point against a source to more of a quality assurance approach that focuses on the systems and processes that generate and report the data. Her presentation focused on the methods of interviewing and root-cause assessment, and how these tools—traditionally used only by auditors—can be used by clinical monitors to effectively ensure the systems that generate and report data from trial sites remain compliant.