Risk-Based Monitoring and Quality Management Plans: An Interdependent Relationship and Factors Influencing Plan Development

Authors

• J Farrell
• A Adams
• J Beeler
• L Giebeig
• D Shelley
• S Simpson
• B Baseler
• J Pierson
• S Vogel

Abstract

This poster provides insight on the interdependent relationship between risk-based monitoring and quality management plans at study sites. High-risk areas of clinical research, such as the informed consent process, eligibility, and safety reporting, will be reviewed as focus areas for risk-based monitoring and site quality management plans. Included is a data set from risk-based clinical monitoring visits and an analysis on the findings and observations noted. By applying this analysis, focus is placed on monitoring these high-risk areas and training the clinical sites to ensure well-established quality review procedures are in place before the start of the study, resulting in positive impacts on quality control at the site level. These specific areas of high risk and quality review procedures to prevent them are highlighted. Any issues noted during risk-based monitoring can be corrected with a Corrective and Preventative Action Plan (CAPA), which can then be incorporated into the site’s quality management processes and plans.

Scientific Focus Area: Research Support Services

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