Description
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, giving you change management strategies, team effectiveness tools, and downloadable implementation tools that you can use immediately. Get a head start in preparing your team and processes for the RBQM transition, as we walk 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. Do not allow yourself to get left behind, but strive to optimize data quality and patient safety in clinical trial conduct by implementing risk-based processes that minimize the potential for error, misconduct, and fraud.
Who should attend?
RBQM Essentials Green Belt training is specifically tailored for the following clinical research roles:
- Risk Manager
- Role implementing RBQM at a company
- Study Manager
- Central Monitor
- Lead Biostatistician
- Lead Data Manager
- Medical Monitor
- Role responsible for programming KRIs/QTLs
- CQA Representative / Auditor
- Lead CRA
- Site Start Up / Regulatory Lead
- Safety Lead
- Medical/Scientific Affairs
NOTE: Prior MyRBQM® Academy White Belt certification is required (learn more…)
After completing the Green Belt training you should be able to…
- Describe the steps in ICH E6 R2 section 5.0 and approaches to implementation
- Identify critical processes and data for a study (as a team member)
- Identify, evaluate and prioritize RBQM risks for a study (as a team member)
- Develop risk controls and the approach to their communication for a study (as a team member)
- Analyze an issue and determine root causes, corrective actions and risk controls (as a team member)
- Describe the interaction of people, process and technology in RBQM activities for clinical trials
- Discuss the impact of RBQM beyond monitoring activities to other processes such as clinical data management, biostatistics and TMF
- Describe a practical example of using the approach of RBQM in clinical trials
Why should you attend?
- Become a certified expert to advance your career
- Achieve compliance in your industry
- Benefit from shared experiences from your industry peers
- 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? Similar to the Lean Six Sigma methodology, RBQM Essentials provides the use of a colored belt tier system for its certification. These certifications indicate the roles that individuals are qualified to play in conducting clinical trials and tutoring risk-based quality management practices. To receive a belt-level certification, students must follow a hierarchical process.
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).
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 by providing their real-life experience, including a live demonstration of a Risk-based Quality Management enabling technology.
Download the full brochure here… or contact us: academy@cyntegrity.com
CURRICULUM | RBQM Essentials Green Belt Course (3 sessions of 2 hours)
- What do the guidelines – ICH E6 & E8 tell us?
- The aim of RBQM
- What’s critical? – Critical Processes & Critical Data
- What can go wrong? – Risk Identification
- How bad could it be? – Risk Evaluation
- How can we manage the risks? – Risk Control
- Why did it happen? And can we stop it happening again? – Issue Management
- How can we ensure those who need to know the risks, know? – Risk Communication
- When, why and how should we review risks? – Risk Review
- What do we report in the CSR? – Risk Reporting
- RBQM Summary
- Hands-on exercise; protocol analysis, RACT, mitigation actions
- Q&A session
The Bonuses
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/
Free of Charge: Cyntegrity’s Golden KRI Set
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 ready-to-go KRIs addressing the most common risks every clinical trial is combatting. Take a look here: https://cyntegrity.com/product/cyntegrity-golden-kri-set/
What are you waiting for… get your verified certificate!
