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Taking the "Risk" Out of Risk-based Monitoring

While risk-based monitoring has gained considerable attention in recent years, reluctance still remains around the approach – from uncertainty arising from the use of “risk” employed in its name to sponsors being wary of potential implications on data quality and regulatory inspection outcomes. This article discusses steps sponsors and CROs can take to successfully implement risk-based monitoring including:

  • Developing monitoring, risk management, and quality management plans
  • Encouraging cross-functional communication
  • Looking at data trends

Lauren McGurk, Senior Clinical Research Associate (CRA)Lauren McGurk has over 17 years of industry and clinical research experience in all phases of development, serving in the roles of Lead/Senior CRA, Site Manager, and Auditor. She is a seasoned clinical team leader with training and mentoring experience and serves as a clinical and regulatory resource for her teams. Lauren has a strong understanding of clinical trial operations and management that has allowed her to successfully lead clinical teams to meet timeline deliverables for various multi-center trials.