58 - Risk Management and Quality Assurance in Clinical Trials (S22E4)

This episode explores the critical processes of risk management and quality assurance within the clinical research environment. It will focus on GMPs, premises, processes, products, and procedures, and how they impact quality. Beyond that, the episode discusses the physical space of equipment and how that impacts the final product.

The episode details effective strategies for monitoring compliance, managing deviations from protocols, and implementing CAPA (Corrective and Preventative Action) measures. These measures play a pivotal role in upholding study integrity, enhancing data reliability, and protecting the safety of participants involved in the research. The importance of accurate and reliable lab control will also be part of the overall discussion.