Risk Management in Clinical Trials

In this 60-min course, we look at the general principles relating to risk management in clinical trials. We utilize relevant regulatory guidance as well as the principles in ICH GCP to help you to understand the risk management process and how this is done.

Content includes:

• The principles of risk-based management of clinical trials
• Who should be involved in a risk assessment?
• Why might risks change as the trial progresses?
• Identification of ‘Critical to Quality Factors’
• The steps involved in a risk-based approach to clinical trials
• Setting Quality Tolerance Levels
• Risks at the system and trial level
• Risk mitigation
• Risk-based monitoring
• Case studies
• Quick quiz to test knowledge
• Glossary of terms.

This course can be customized to meet your processes and requirements.

For details of packages for training larger groups contact us at info@brookwood-global.com