An essential component of risk-based quality management (RBQM), as detailed in both the ICH E8 (R1) and ICH E6 (R2) GCP guidelines, is to perform proactive assessments of risk starting with the initial design of a study, again during study planning, and as needed throughout study execution. Important risks identified at each stage should result in actions (“mitigations”) designed to minimize the likelihood or impact of those risks to patient safety and/or reliability of the study results.
