ICH GCP R3 E-Learning Course

Woodgate Carnegie ICH GCP R3 E-Learning Online Course: £60.00

• 5 interactive e-learning modules.
• 3-5+ hours to complete the course.
• Additional engaging content for further reading.
• Quizzes to ensure optimal learning.
• Downloadable electronic ICH GCP R3 certificate

This course meets ICH GCP Training Requirements for all roles involved in conducting Clinical Trials. Major changes from R2 to R3 are highlighted within the course content.

Course objectives

• To introduce the ICH organisation and a brief history of ICH GCP E6
• To appreciate the aims of the ICH GCP E6 R3 Guideline
• To highlight the main changes in ICH GCP E6 R3 and how they will impact your role and your organisation
• To become familiar with the structure and content of ICH GCP E6 in such a way that you can reach relevant information when required in your role

Who prepared and built this course?

Hilary Birrell

Head of Clinical Operations and Founder, Carnegie Clinical Research Ltd, Head of Clinical Operations and Board Director, VasoDynamics Ltd.

Hilary is a Biochemist with three decades of experience in Clinical Trial Operations and training.

Hilary began her career in AstraZeneca in management and monitoring of pre-registration trials of Omeprazole, followed by 7 years in a Good Clinical Practice and Training role.

She then established a Clinical Trial Consultancy, GCP Scotland in 2001, and founded Clinical Research Organisation, Carnegie Clinical Research Ltd in 2010.

Hilary has experience across trials in multiple therapeutic areas and across all drug development phases (I-IV).

Experienced in setting up Clinical Operations Departments for emerging biotechs; working with Academic Clinical Trial Units in UK and Europe; and training operational teams and investigational sites in ICH GCP and clinical trial management.

Hilary retains a strong interest in the practical application of clinical trial guidelines and regulations to ensure safety of patients in clinical trials, and the delivery of high-quality clinical trial data.

Hilary is part-time Head of Clinical Operations for London-based Biotech company, VasoDynamics Ltd and currently serving a tenure as VDL Board Director.

Amy Woodgate

Founder and Director Woodgate Consulting Ltd

Amy is an online learning consultant specialising in digital strategy and learning at scale. She is the director and founder of Woodgate Consulting - an online learning strategy and production consultancy, which leads design and implementation of digitally mindful but purpose-driven learning experiences.

Values are core to the vision of Amy's digital disruption, embracing strong collaborative and open practice, and driven by a desire to create learning solutions people love.

Reviews from course attendees

"I just completed the ICH GCP E6 R3 training and wanted to thank you! The whole training is designed in such an amazing manner that you don't get bored while undertaking it (which is quite common).

The additional information and hints mentioned next to the clauses and sub-clauses were too useful and reflected the actual practical aspects and scenarios which were so helpful in understanding their actual utility. Thank you for making it concise, easily understandable and interesting."

Clinical Trial Monitor and Pharmacist

"I was impressed with the quality and depth of the content. The course provides a well-structured overview following the recent updates to the ICH E6(R3) guidelines, ensuring that participants fully understand the principles of Good Clinical Practice (GCP) in the context of modern clinical trials. The platform was user-friendly and the pace of the course was just right, with interactive elements reinforcing the material in an engaging way.

Overall, I highly recommend this course to anyone involved in clinical research, whether you're looking to stay current with regulatory requirements or seeking a deeper understanding of GCP."

Operations and Quality Manager. Pharmacovigilance Safety Database Vendor, UK

"GCP training written by professionals in the field, delivered in a clear, jargon-busting way, and applicable for both experienced and novices in clinical trials."

Academic Clinical Projects Manager, UK

FAQs

What are the key differences between the updated GCP guidelines and the previous version?

The updates build on the existing guidelines, with a new structure, expanded information within the ICH GCP principles, and additional guidance throughout to align with modern day clinical trial design and management. Importantly, future-proof guidance is included to keep pace with advances in trial designs and clinical trial technologies.

The key differences in R3 cover the following areas:

• Risk Proportionate approaches and robust risk management included in Quality Management systems across the clinical trial life cycle.
• Use of Innovative Clinical Trial Designs and methodologies.
• Additional requirements for effective trial oversight by sponsor organisations.
• Use of advances in clinical trial technologies to facilitate clinical trial conduct, reduce patient burden and increase diversity in clinical trials.
• Inclusion of all trial stakeholders, including patient engagement, in trial planning.
• New and extensive Data Governance requirements, covering digital technologies used across clinical trials and ensuring adequate data retention and preservation for up to 25 years in some cases.

Who needs to be aware of these updates and how will they impact my role in clinical trials?

These updates are relevant to all roles working in Clinical Trials e.g. sponsor companies and clinical operational teams, contract research organisations (service providers), academic clinical trial units, healthcare professionals in clinical trials, those working on clinical trial data collection and archiving.

When will these updated guidelines come into effect?

The updated ICH GCP E6 guidelines have been published (Step 4). Legislation and timings on their adoption within regulatory regions and countries varies and users should check current legislation and timelines for adoption for the regions/countries in which they are conducting their clinical trials.

How was this course created?

We have carefully chosen the written and visual content of this course to cover the breadth and depth of topics covered within the guideline and to provide an engaging learning experience.

Hilary's experience in clinical trial management and training guided the selection of additional resources referenced in the course.

None of the content has been outsourced to AI.

Written content is based on ICH GCP E6 R3, released under copyright with rights granted to use, reproduce, incorporate into other works, adapt, modify, translate or distributed under a public license provided that ICH's copyright in the document is acknowledged at all times.