Does your organization understand risk and how to implement risk management in your clinical research program? MCC is pleased to announce that MCC eLearning Course 301 – Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2): Fundamentals of Clinical Trial Risk Management is available for purchase in the MCC store (MCC members receive a 20% discount).
This course is an expanded, upgraded version of a complimentary live webinar presented by Linda Sullivan, MCC Co-Founder and Executive Director and Keith Dorricott, MCC Ambassador in October 2018. Due to the overwhelming response and positive feedback, the webinar content was expanded into a one-hour, hands-on, on-demand training course during which Linda and Keith walk through risk management concepts, and learners apply the concepts by reviewing a case example and completing the risk assessment and control log included in the course material.
At the conclusion of the course, learners are 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 and use process maps to identify areas of risk
- Develop risk statements and evaluate risk
- Describe approaches to controlling risks in clinical research
- Mitigate some common implementation challenges
You have to develop and implement risk-based quality management programs to comply with ICH E6(R2). You owe it to yourself to discover how.