Risk Management in Clinical Research
Risk management is becoming increasingly important to running clinical trials and ensuring compliance with regulatory expectations. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9 and the revised ICH GCP R2 guideline.
This essential one-day course will explain the importance of using risk management techniques in clinical research to comply with the latest focus on inspection in this area. It will show you how risk management can improve the quality of your clinical trials and demonstrate the importance of using risk analysis and risk management techniques in clinical trials and risk-based monitoring. You will learn how to identify, evaluate and implement specific risk-based techniques for risk management used in clinical trials.
This course will enable you to develop quality risk management principles applicable to clinical research, as well as to identify and share best practices for implementing risk management tools and approaches.
Benefits of attending:
- Understand risk management tools and when and how the tools are used in clinical research projects
- Learn how to plan risk-based approaches, how to document and where to focus to meet regulatory requirements and expectations
- Develop and apply risk management principles and tools to your clinical trials, including risk-based monitoring
- Identify and share best practices for implementing risk-based tools and principles
Who should attend?
Anyone working on clinical trials including CRAs, monitors, clinical managers, project managers, lead clinical research associates, data managers, statisticians, study managers and those in QA/audit/QC and document management. It will also be relevant to those who work alongside the study team, such as regulatory affairs and pharmacovigilance.