Be Audit Proof, Always!

Description
Operational

As a clinical researcher, you should always be ready for an audit. This TRIUM training will uncover the secret to become ‘audit proof’ at any time.

The only evidence for regulatory compliance whiles ensuring subject safety and well-being and quality data are the essential – and source documents related to the clinical trial. After an introduction on audits, expectations and behaviors, a practical session using a real TMF will follow. The trainer, who is also an auditor in real life, will review the TMF together with the participants whiles acting and asking questions as if she was auditing. Participants will learn hands-on how the documents need to be aligned and ‘tell the story’ of the trial to any stakeholder.

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

Note: Upfront approval from the sponsor for the use of the TMF will be assured. A CDA will be required to sign for any participants not working on the trial for which the TMF is used.

Learning objectives

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

  • Define audits and explain the difference with inspections
  • List the organizational and behavioral expectations to ensure a successful audit
  • Critically assess your TMF for being ‘audit proof’
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.”