Why is this training so important?
Protocol Risk Assessment is the genesis of the new Quality Management section (5) of ICH E6 (R2) and core to the principles of quality by design (QBD). It drives much of the downstream quality planning and management activity during the course of a clinical trial and yet it is something we find many companies struggle to get started with.
Getting it right can mean that all functions have access to a well structured, well defined approach to the identification of risks to quality and approaches to dealing with those risks and their causes. It allows us to achieve the following:
- Early mitigation of risks through early planning and trial design.
- Better usage of clinical trial data for proactive risk identification.
- Clear identification of quality thresholds.
- Clear definition of what to do when a threshold is breached and who is responsible.
- Guidance on root cause analysis.
- A clear entry point into the practice of risk-based monitoring (RBM).
- Enterprise wide learning and capability development.
Getting it wrong, or not doing it at all can mean important risks are missed, patient safety and data quality may be compromised, and a likely return to the old, inefficient approach of focusing on everything (i.e. focusing on nothing) where monitoring and data review are concerned.
What will we cover?
The training has been designed to take the audience from a high level regulatory and psychological perspective on risk management, through a practical framework for performing risk assessment and management, followed by some specific case study examples.
- Regulatory context of protocol risk assessment
- The goals of quality risk management
- Risk management theory
- Risk Assessment – why is it so difficult?
- Risk Identification and Evaluation
- Risk Control
- Risk Communication / Documentation
- Summary and key points
Why are we running it?
If you look back at our website, you will see that since we started TRI we have been committed to communicating and sharing our ideas and experience with our industry colleagues and customers. We find that the more we work for industry, the more the industry wants to work with us, and so everybody wins!
We all know people who are either in clinical trials, or using drugs developed as a result of clinical trials, and hence we all understand the importance of safety and quality.
The bottom line is - this is important, on many levels and the faster industry adopts these practices the better.