ICH GCP E6 (R2). Risk Assessments and Control Skills to Decide on Risk-based Monitoring Strategies.


Conducting risk assessments is a key part of any clinical QMS and the first step into deciding the most efficient and effective monitoring strategies for your trial. The results of the risk assessment are used to decide on a risk-based monitoring strategy that suits the needs of the trial best. This TRIUM Session will ensure a proper understanding of the definitions of risks, risk management and risk-based monitoring strategies and plans and lists the different steps involved in conducting risk assessments to get you on the right track.

At the end, you will receive a certificate and handy hand-outs for later use.

Learning objectives

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

  • Define risks, risk-based monitoring techniques and plans
  • Describe the steps involved in conducting risk assessments
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.

Esther Daemen
Esther Daemen 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.”