Addendum to ICH GCP E6 (R2): The Impact on your Site’s Daily Research Reality

Description
Regulatory

The ICH GCP E6 (R1) guideline had been around since 1996. With the world changing at a very fast pace with increases in globalization, study complexity and technologic capabilities an update was long due. The ICH GCP E6 Addendum took effect in November 2016, offering an improved and more efficient approach to clinical trial design, oversight, conduct, recording and reporting to even better ensure human subject protection, quality of data and efficiency of industry. More specific recommendations are made to facilitate innovative clinical trial approaches including quality risk management and quality-by-design processes which emphasize upfront assessment of risks specific to a study design and protocol.

This TRIUM Session provides a to the point update on what exactly changed compared to the ICH GCP E6 R1 version. But most importantly it will cover the impact on the sponsor- and investigator’s responsibilities and the overall daily research reality of both.  A refresher of the IRB/EC responsibilities will be covered as well to complete the full story.

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

Learning objectives

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

  • Describe the investigator, sponsor and IRB/EC responsibilities
  • Describe what changed in ICH GCP E6 R2 and why
  • Critically assess the impact for sponsors and investigators of these changes
  • List actions to be taken in the daily research environment to ensure compliance with ICH GCP E6 R2
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.”