Start with critical quality.
RBQM starts with factors that meaningfully affect participants’ rights, safety and well-being and the reliability of trial results. ICH E6(R3) connects the CtQ concepts in ICH E8(R1) with a proportionate, risk-based approach to quality management.
Design the path from control to action.
For each important risk, clarify existing controls, further actions and who will decide and execute. Recording risk scores without connecting review and action is unlikely to change operations.
Give every metric a next step.
Before adding a metric, ask: what risk might a change indicate, who will check it and what action could follow? Define data, review intervals, decision evidence and follow-up together.
One practical starting point
Take one important risk and map CtQ → risk → control → review information → owner → action → effectiveness check. This connected flow is OrioNex’s suggested practical starting point.