The RBQM Essentials Green Belt training takes you step-by-step through the critical components you must have in your RBQM Plan.
What if… you could implement your RBQM strategy effectively and efficiently, have your teams embrace the process and contribute to its success while being confident that your strategy has the key components it needs to meet regulatory expectations?
RBQM Essentials is a series of courses that goes beyond the basics of the regulations and gives you change management strategies, team effectiveness tools and downloadable implementation tools you can use immediately, and takes you step-by-step through the key components you need to have in your risk-based quality management strategy.
Clinical researchers who earn RBQM Essentials certification become key stakeholders in improving the output of clinical operations within their organizations. They strive to optimize data quality and patient safety in clinical trial conduct by implementing risk-based processes and establishing metrics, KRIs, KPIs, and QTLs, that minimize the potential for error, misconduct and fraud.
Who should attend?
- Clinical Project Management staff, Clinical Operations staff, Data Managers, Quality Management staff, Statisticians, Pharmacovigilance staff, CRAs / Monitors and all other Clinical Research Professionals
Similarly to the Lean Six Sigma methodology, RBQM Essentials provides the use of a colored belt tier system for its certification. To receive a belt level certification, students must follow a hierarchical process.
NOTE: Prior MyRBQM® Academy White Belt certification is required (learn more…)
Why should you attend?
- Become a certified expert to advance your career
- Achieve compliance in your industry
- Join the exclusive MyRBQM® Academy Alumni community
- The bonuses beyond the course content itself…
RBQM Essentials – Belt Level Rankings
But what do RBQM Essentials belt levels mean? These certifications indicate the roles that individuals are qualified to play in conducting clinical trials and tutoring risk-based quality management practices. RBQM Essentials’ belt certifications equip clinical research professionals to be active participants in optimizing their company quality culture and avoiding downtime.
Get to know each of the rankings so you can build skills that will help your organization function more smoothly and advance your career.
Green Belt: virtual instructor-led classes
The RBQM Essentials ‘Green Belt’ is a clinical research professional who is well versed in the core to advanced elements of the Risk-Based Quality Management methodology, who leads clinical trials and/or serves as a clinical study team member. A Green Belt possesses a thorough understanding of all aspects of the Risk-Based Monitoring method including competence in subject matters contained within the phases of risk detection, evaluation, control, communication, review, and reporting as defined by ICH Good Clinical Practice E6 (R2).
An RBQM Essentials Green Belt understands how to implement and apply Risk Assessment and Categorization Tools (RACTs) and how to implement, apply and interpret the concept of Key Risk Indicators at a high level of proficiency.
How does it work?
Through an interactive approach the webinar style workshop will provide lessons, case studies and hands-on sessions, allowing you to implement RBQM in your daily practice. There will be room for knowledge sharing with all participants, so that you will benefit not only from the trainer’s but also learn from each other’s experiences.
Our industry experts contribute to the workshops providing their real-life experience, including a live demonstration of a Risk-based Quality Management enabling technology.
Download the full brochure here…
CURRICULUM | RBQM Essentials Green Belt Course (3 sessions of 2 hours)
- The basis for adaptive risk-based monitoring
- Planning of Source Data Verification (SDV) adjustments and monitoring visit schedules
- Adjusting on-site monitoring and adopt centralized monitoring
- Trial design, operational and IMP-related risk areas
- Study and site level critical components your risk-based monitoring plan must reflect on
- Critical data that you should always monitor
- Risk-based monitoring tapering
- RB(Q)M efficacy and efficiency assessment, from pilot to full implementation
- RB(Q)M metrics; how to measure poor performance and non-compliance
- How to evaluate RB(Q)M effectiveness during trial conduct
- Identification of systemic issues and their root causes
- Introducing Key Risk Indicators
- Warning signals that will inform you when and how to increase SDV at clinical sites
- Group session: interactive risk assessment and data analysis of generic study
The Green Belt course comes with bonuses beyond the course content itself:
Free of Charge: Risk Management Plan Tool
The tool is the perfect template for a high-quality risk management plan for your next clinical trial. It helps you to save time and effort by providing structure and guidance towards each aspect of your risk management plan. Take a look here: https://cyntegrity.com/product/risk-management-plan-tool/
Cyntegrity’s “Golden Set” of KRIs
Based on years of clinical research expertise in data quality and statistical data mining, we’ve extracted for you a golden set of over 25 specified and validated, i.e. ready-to-go, KRIs addressing the most common risks every clinical trials is combatting.
What are you waiting for… get your verified certificate!