An introductory capability module designed to help individuals and cross-functional teams understand how RBQM is applied in practice.
This is the entry point to the pathway, designed to establish a shared understanding of RBQM across functions. If you are new to RBQM or preparing a team for a rollout, this module provides the baseline needed before moving into applied implementation.
This module is commonly used when organizations want to establish a shared understanding of RBQM principles before operational rollout or process transformation activities begin.
It helps cross-functional teams understand how concepts such as Quality by Design (QbD), Critical-to-Quality factors (CtQ), Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs) connect to daily clinical trial activities and oversight responsibilities.
The course is frequently used as onboarding for new team members, as preparation before Green Belt implementation training, or when different functions require a more aligned interpretation of RBQM expectations under ICH E6(R3).
Sponsor and CRO teams also use this module to create a consistent RBQM language across departments before introducing centralized monitoring workflows, risk review processes, or study-level governance activities.
