Risk-Based Quality Management (RBQM) will be the operational foundation of next-generation clinical research. RBQM mandates new ways of thinking and operating that will change the clinical development process, from the concept and design of clinical trials to the infrastructure and methodologies used to conduct them.

A broad constellation of regulatory guidance is in progress to inform sponsors as industry implements this far-reaching revolution. In a two-part series, this first paper outlines the quality and regulatory thinking that underpins RBQM, and details essential points of compliance for emerging ICH core guidances on RBQM—including ICH E8 (R1) and ICH GCP E6 (R3)—and offers further discussion of RBQM implications for sponsors, clinical sites and patients.