Using a “risk-based” approach has paid big dividends in clinical trials, as its principles are applicable to many different functional areas. This is no more visible than when applied to the oversight of Clinical Research Associates (CRA). Understanding how to use this approach when managing CRAs can help improve the quality, efficacy and efficiency of your trials.
This course presents tools for CRA selection, assignment and oversight that are based on quality risk management principles. This approach can support cost containment for non-project specific activities such as monitor oversight. You will learn to apply risk management models to GCP monitoring management and proactively plan quality monitoring evaluations based on risks from the protocol, the monitor and the site. Furthermore, you will learn to use resources wisely for monitoring oversight activities and budget for these activities.
Attend this interactive 90-minute session and you will be able to:
- Recognize the benefit of quality risk management models and tools applied to monitoring assignment and evaluation
- Apply quality risk management concepts when planning monitoring oversight
- Identify how to prioritize monitoring evaluation visits