This course provides an understanding of risk management principles and makes the links between study level risk management and the implementation of risk based monitoring.
New regulations with regard to Risk Based Monitoring were released by FDA in August 2013 to build on those for Quality Risk Management (ICH Q9) released in 2005 by ICH and 2006 by FDA. In addition there is permanent pressure on resources for clinical trials and it is vital that those precious resources are utilized there they deliver greatest benefit.
The implementation of risk-based study specific monitoring strategies, plans will be a critical component for every study sponsor to ensure high quality and integrity of data, enhance human subject protection, reduce cost and eliminate inefficiencies across clinical trial process. Thorough identification and evaluation of risks to critical study data, processes and thereby designing appropriate monitoring plan with a balance of centralized & onsite monitoring will maximize the effectiveness of risk based monitoring.
Considering the importance and need of risk-based monitoring currently in clinical trial management, it is recommended to attend this webinar that provides more insight on this new approach.
Areas Covered in the Session :
Broad review of risk based activities
Study level risk management
RBM – adding value to your operations
What may generate risk?
Risk management documentation/risk statement structure
How to get started
Actions and how to manage them
Who Will Benefit:
A must attend webinar for all:
Clinical Research Associates
Data Management Team
Project Management Statisticians
Clinical Research Outsourcing
All clinical research professional embarking on a risk-based approach