Description
The RBQM Essentials Black Belt training is dedicated to ensuring you have the change management strategies you and your team need to create sustainable change.
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?
Through all of its 4 Modules, RBQM Essentials Black 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
NOTE: Prior MyRBQM® Academy White Belt and Green Belt certification are required (learn more…)
After completing all 4 Black Belt training Modules, you should be able to…
- BB Module 1: Designing KRIs & QTLs; Metrics, Thresholds, and Signals
- Interpret data from KRIs and QTLs to detect risk signals
- Interpret data from Statistical Data Monitoring to detect risk signals
- Describe some of the most common KRIs used and why they are useful
- Perform root cause analysis
- Discuss methods to influence others on your findings
- BB Module 2: Central Monitoring During a Study
- Define KRIs and QTLs
- Summarize different approaches to threshold definition and use
- Give examples of considerations when programming and verifying KRIs and QTLs
- Select the optimal graphical representations of KRIs and QTLs
- BB Module 3: Facilitating RBQM in Clinical Trials
- Lead a team to identify critical processes and data for a study
- Lead a team to identify, evaluate and prioritize RBQM risks for a study
- Lead a team to develop risk controls and the approach to their communication for a study
- Lead a team to analyse an issue and determine root causes, corrective actions and risk controls
- BB Module 4: Change Management
- Discuss how change management is vital for successful implementation of RBQM in an organization
- Demonstrate an understanding of the Change Curve and its implications
- Describe methods for helping people and organizations change
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? 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.
Black Belt: virtual instructor-led classes
A ‘Black Belt’ understands change management philosophies and RBQM principles, including the supporting Clinical Trial Risk Management (CTRM) systems and tools. This person demonstrates team leadership and understands all aspects of the Kübler–Ross model in accordance with RBQM principles.
Black Belts are known as agents of change within an organization. They have a deep understanding of team dynamics and handle assigning roles and responsibilities to team members. Most often these team members are Green Belts.
It is the goal of a Black Belt to improve overall quality and profitability.
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 and change management 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 Black Belt Course (3 sessions of 2 hours)
- BB Module 1: Designing KRIs & QTLs; Metrics, Thresholds, and Signals
- General Overview (Reminder)
- Designing KRIs
- Tresholds
- QTLs
- Summary
- Q&A
- BB Module 2: Central Monitoring During a Study
- General Overview (Reminder)
- KRIs
- QTLs
- Central Statistical Monitoring
- Handling (Potential) Issues
- Influencing Others
- Q&A
- BB Module 3: Facilitating RBQM in Clinical Trials
- General Overview (Reminder)
- The Role of Facilitating
- Risk Assessment
- Risk Control
- Don’t Forget!
- Summary
- Q&A
- BB Module 4: Change Management
- The (in)Famous Change Curve
- The Adaptable Human
- Change vs Transition
- Change Management
- Phases of Change and Common Behaviors
- Dealing with Resistance
- RBQM Implementation: Take a Phased Approach
- Q&A
- Certification Project
The Bonus
The Black Belt course comes with a bonus beyond the course content itself:
Free of Charge: Adaptive Monitoring for Clinical Trials (Flowcharts)
The complete set of the Adaptive Monitoring process flowcharts including description. Risk-based Quality Management integrates the Adaptive Monitoring (AM) process, which addresses all aspects of quality risk management. The AM concept incorporates people, process, and technology yielding the greatest impact on quality, effectiveness, and cost savings.
Take a look here: https://cyntegrity.com/product/adaptive-monitoring-for-clinical-trials-flowcharts/
What are you waiting for… get your verified certificate!
