Risk Management and Risk Based Monitoring (RBM) Plans

Description
Operational

It has been more than five years by now that the risk-based approaches were introduced and recommended to be used, and even became mandatory for the conduct of clinical trials. However, in real life still a lot of sponsors and sites struggle with its implementation. This mostly due to lack of understanding of its strategies and implementation, making people think it is too complicated and expensive.

This TRIUM training provides insights into the strategies and steps to follow for setting up a company-wide risk management plan that can be used for all trials, including tips on ensuring a successful change management process and stakeholders’buy-in. Next the outcome of the risk assessments done as per the risk management plan will be translated into a lean, feasible and affordable risk-based monitoring plan. The trainer, who is a strategic risk-management consultant in real life, will share real case studies and examples to ensure proper practical understanding. Risk-based approaches can be simple and affordable, whiles ensuring a healthy ROI after the initial investments of time and resources. Risk management does not have to be costly and daunting, in other words, it is not a risk but an opportunity to ensure efficiencies. You should be equally convinced of this after this training as the trainer.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Define risk management and risk-based monitoring
  • Describe the strategies and steps for creating a risk management plan
  • Write a risk-based monitoring plan based on the risk assessments following the company wide plan
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Esther Daemen
Esther Daemen is currently ‘Quality &Training Director – Data Protection manager’ at TRIUM Clinical Consulting and has over 27 years of working experience in the healthcare/pharma & device field. She served many organizations in different research roles and as professional development director at ACRP global. She gained a bachelor’s in nursing and earned project management, training and DPO certificates as well as and a master´s degree in Business. Esther is also a highly sought-after presenter at professional conferences/universities and a writer of peer-reviewed articles for professional magazines like ‘The Clinical Researcher’. Her work was rewarded by the KP Morgan 'OECT Summit 10Years Speaker Achievement Award' in 2020, the ‘Best trainer to watch’ 2010 Training Magazine award and by having her organization ‘Kendle’ being listed as one of the top 125 training providers in the world in 2008. "TRIUM is an expert Contract Research Organization that offers a unique combination of global CRO services, staffing solutions, quality services, GDPR consultancy and risk-based approaches as well as training services. It’s our mission to be a passionate, dedicated business partner with a focus on excellence to provide start‐to‐finish clinical trial activities tailored to the timing, budget and specific needs of the Sponsor.”