COVID-19 Impact Risk Assessment for Clinical Trials: Example Questions and Plans to Cover the Highest Risks.

Description
General

The COVID-19 pandemic obliges sponsors and clinical researchers in general to conduct an impact risk assessment for their trials. If you are not sure where to start, or want confirmation of the accuracy and completeness of what you did thus far, then join this TRIUM live online workshop. Two quality experts will share what critical questions to pose to cover the highest risks through an example risk assessment log, aligned with the TransCelerate structure, that can be used as a template or starting point.  This log is included in the price and will be shared during the training with each attendee.

In this repeat session emphasis will be laid on up to date regulatory body expectations and the expected status of the risk assessment after weeks of COVID-19 measures. We also ensure plenty of opportunity for questions and discussions through open mics. Attendees say this was ‘Timely, to the point and very helpful’!

Learning objectives

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

  • List the official recommendation documents shared by the regulatory bodies
  • Describe the key considerations and take-aways to ensure patient safety, data quality and overall compliance
  • Start or continue your trial related risk assessment and management
  • Prioritize actions taken per the highest risks identified
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.”