What you will learn
- How to review the basic principles of risk management and utilize them to take a ‘risk-based approach’
- How authorities interpret the ICH GCP E6(R2) through review of inspection/audit findings
- How to document, prioritize risks and plan mitigation activities and their measurements
- How to develop descriptive metrics for your risks
- How to identify acceptance criteria and actions
- How to review and document your approach
- How to discuss methods to communicate and report the approach taken and share best practice
What your company will get
- A clinical research professional who understands the principles of risk management and application in a clinical research setting
- An employee who will be able to utilize a risk-based approach and define measurable metrics to report on the actual progress for all stages of the clinical trial process from study design, study conduct to study reporting
- A professional who can identify and evaluate risks to critical study processes and data and employ mitigation and corrective and preventive action where indicated
- A professional who can provide valuable input towards implementation of a risk-based approach across all disciplines within a clinical research unit