As guidance changes and clinical trials modernize, the way that companies think about quality and risk in the design and conduct of a study must evolve as well. SCOPE’s 11th Annual Clinical Quality and Risk Management stream will provide an opportunity for clinical operations leaders to exchange best practices, case studies, and in-depth strategies for integrating a risk-based approach throughout the clinical research cycle and across functional areas. The program will explore ways of leveraging RBQM technologies to achieve study plan goals, the impact of ICH E6 R3 on study conduct, usage of data science for a risk-based approach, and key insights for regulatory compliance.