Progress from foundational RBQM understanding to practical study-level application through a combined White Belt and Green Belt learning pathway.
This bundled learning pathway is designed for individuals and teams who need to build both foundational RBQM understanding and practical operational application within clinical trial environments.
Participants begin with the White Belt module to establish a shared understanding of Quality by Design (QbD), Critical-to-Quality factors (CtQ), Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and risk-based oversight principles.
The pathway then progresses into the Green Belt module, where learners apply these concepts to study-level decision-making, risk evaluation, centralized monitoring activities, mitigation planning, and cross-functional collaboration in realistic clinical trial scenarios.
The combined structure supports a more consistent and scalable approach to RBQM capability-building across sponsor and CRO organizations operating under ICH E6(R3) and E8(R1).
This bundled pathway is commonly used by individuals and teams who need to build both foundational RBQM understanding and practical operational application within clinical trial environments.
Organizations frequently use the combined White Belt and Green Belt pathway before introducing RBQM processes into active studies, centralized monitoring activities, or broader risk-based oversight initiatives under ICH E6(R3) and E8(R1).
The bundle supports cross-functional onboarding across Clinical Operations, QA, Medical Monitoring, Data Management, Centralized Monitoring, and study leadership functions by creating a more aligned understanding of RBQM terminology, oversight expectations, KRIs, QTLs, and risk evaluation approaches.
It is also used as a structured capability-building pathway for sponsor and CRO teams preparing for operational RBQM rollout, governance activities, or progression toward more advanced implementation and leadership training.
• Two self-paced e-courses combining foundational RBQM understanding and applied operational learning
• White Belt (~80 minutes) and Green Belt (~6 hours) delivered fully online
• Includes lessons, applied exercises, practical study scenarios, and hands-on RBQM activities
• Covers QbD, CtQ, KRIs, QTLs, centralized monitoring, mitigation planning, and study oversight concepts
• Includes practical implementation templates and RBQM reference materials
• Certificate awarded upon successful completion of each module
• 2 years of access to all course materials
The combined pathway supports scalable RBQM capability-building across sponsor and CRO organizations by progressing learners from foundational awareness toward practical study-level application and operational oversight activities.
Recommended learning pathway:
Participants are encouraged to complete White Belt before progressing to Green Belt to establish a strong foundation in RBQM principles, terminology, and regulatory expectations.
