The most profound change in the updated ICH GCP E6 R2 is the new sponsor responsibility, Section 5.0, Quality Management. This section provides detail on implementing a system of quality management; critical process and data identification; risk identification; risk evaluation; risk control; risk communication; risk review; and risk reporting. Further, risk assessment and risk mitigation plans are required, regardless of whether Risk-Based Quality Management (RBQM) is being utilized by the sponsor. These requirements also address: Efficient clinical trial protocol design; data collection tools/ procedures; and, collection of information that is essential to decision making. This web seminar takes an in-depth look at the updated guideline with respect to quality management, as well as the methodology of RBQM. How to apply these guidelines in a step-by-step process with strategies for effective implementation will be reviewed and an example provided.
- Define the three-way risk evaluation methodology
- Distinguish between the concepts of risk mitigation and risk acceptance
- Describe the concept of “predefined tolerance limits”
- Describe centralized monitoring
- Define a best practice implementation process based on practical experience
- Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management
- Study Managers/Project Managers, Clinical Research Associates/Monitors (Centralized, On-site)
- Business Process Owners
Mary Mills, R.N., C.C.R.A.
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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.