Mini Workshop

Risk-Based Quality Management Critical Thinking Workshop — What Can Go Wrong?

Tuesday, September 28, 2021, 12:30 PM - 2:30 PM

During this 2-hour workshop, participants will view short, online e-learning training videos that review risk management concepts and apply the concepts in “hands-on”, virtual activities and interactive discussion. The topics covered in the workshop include:

• What is risk? How does it apply to clinical trials?
• Identifying and evaluating risks in clinical trials – starting with the critical data and processes
• Controlling risks, risks that become issues, implementation challenges

Learning Objectives:
At the end of the workshop, participants will be able to:

• Explain the concept of risk and its management
• Describe risk management in clinical research and the relevance of ICH E6 (R2)
• Identify critical data and processes
• Use process maps to identify areas of risk by asking “what can go wrong?”
• Develop risk statements and quantify risk
• Describe approaches to controlling risks in clinical research
• Mitigate some common implementation challenges

Faculty: