Implementing the most efficient strategies for monitoring is crucial to reduce the risks and costs associated with your clinical trial - it is estimated that sponsors can save 23% of trial costs with a risk-based approach.
This course will assess the practicalities of implementing a risk-based approach and will demonstrate how risk based monitoring can contribute to better oversight of your clinical studies.
Over 4 weeks you will explore the requirements for risk-based monitoring and targeted Source Data Verification (SDV) including which factors influence the scope of on-site SDV vs. remote SDV. Monitoring aspects will be assessed based on a standard risk assessment for investigational sites and how it can be applied.
What will you learn?
- Fully understand the concept of a ‘risk-based approach’
- Develop contingency plans and get practical advice for making decisions on acceptable levels of deviation
- Explore the practicalities and impact of transitioning to a risk-based approach to monitoring without impacting deliverables
- Examine how the protocol should be designed and the risk-based criteria set
- Define the process, metrics and role of design in a targeted and remote monitoring approach
- Understand the capabilities of automated approaches to assist monitoring clinical trials
- Get practical advice for employing a risk-based approach in a global context
This course is relevant to anyone who would like to develop a better understanding of a risk-based approach, including (but not limited to) Heads/Directors/Managers/Specialists from the following departments:
- Clinical Monitoring
- Clinical Operations
- Data Management
- Study Management
- Quality Assurance
This online academy course can be accessed from Monday 2nd October. Two modules will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.
Module 1: The Basics of Risk Management and the Regulatory Background
- Gain an overview of risk management in clinical trials
- Review the regulatory background to RbM & SDV
- What do Regulators expect from a risk based approach
Module 2: The Foundation of RbM and SDV
- Define a risk based approach to managing & monitoring clinical trials
- Quality by Design in drug development
- Protocol writing rules
- Site qualification
- Risk management and continuous risk assessment
Module 3: Protocol and Study Design and its Risks
- Explore how a protocol should be designed
- How can study set up influence the monitoring plan
- Study inclusion/exclusion criteria and the underlying design and study schedule
Module 4: Site Selection/Qualification and their Risks: Base Lining the Risks in a Trial
- QRM as an indicator of prospective risks
- Base lining the risks in a trial
- How to build a base risk profile
Module 5: Key Risk Indicators - How to Build Them and How they Work
- Identifying KRIs
- Quality by Design assessment to management risk before study start
- Infrastructure risk
- KRI measurement and reporting
Module 6: Risk-Based Monitoring: Activities Based on Base Line Risks and KRIs
- Overview of assessment tools available for identifying signals and inconsistencies
- Site perspective
- Resources and execution
- Quality management
Module 7: Source Data Verification Options and How to Choose Them
- Practicalities of implementing targeted Source Data Verification (SDV)
- When is SDV really needed?
- Pros vs Cons
Module 8: Change Management in RbM: The Changes to Roles in Clinical Development
- Practical advice for phasing in a new strategy without impacting deliverables
- Defining new roles in clinical development: Senior management, QA, HR and operations
Dr. Schiemann is Managing Partner at Widler & Schiemann Ltd, a consulting firm working in the area of quality management in clinical trials and drug safety out of Zug, Switzerland. He is pharmacist by training and obtained his PhD in human biology from Philipps University in Marburg, Germany. He started his career in the pharmaceutical industry in 1996 by joining Roche in Switzerland. From 1999 to 2003 he worked with PricewaterhouseCoopers as a consultant in R&D Strategy in Switzerland and the US. During this time he obtained his postgraduate degree of Pharmaceutical Medicine from the University of Basel and a cMBA on International Marketing from Jones International University in Colorado, USA. He re-joined Roche in the US in 2003. In 2012 he co-founded Widler & Schiemann Ltd together with Beat Widler.