Preparing for the ICH GCP E6 R3 update: What learners need to know

by | Dec 12, 2024 | updates law & regulations

Preparing for the ICH GCP E6 R3 update: What learners need to know GCP Central

Most likely, the International Council for Harmonisation (ICH) will release the updated Good Clinical Practices (E6) R3 guidelines early 2025. This change represents a significant shift in the setup of the guideline that has been around since 1996. Since the development of the ICH GCP Guideline, the scale, complexity and cost of clinical trials have increased, and we moved from paper-based trials to electronic data recording. This change led to the second version of the GCP guideline in 2016: the ICH-GCP R2 Addendum. Now, only 8 years later, we are facing the biggest change in the Good Clinical Practice guideline since its inception.  

The ICH GCP E6 R3 intends to address the application of the GCP guideline to the increasingly diverse trial types and data sources being employed in drug development. As clinical trials and with that, it’s guidelines and regulations evolve, it is crucial for professionals in the industry to stay informed and adapt. This article explores what learners need to know about the upcoming Good Clinical Practice update and how GCP Central’s innovative GCP training can help them succeed. 

Key Changes in ICH GCP E6 R3 

The goal of the new ICH GCP E6 R3 guidelines is to provide flexibility to facilitate the use of technological innovations in clinical trials, and the use of modern clinical trial methods. We have written extensively about these in part 1 and part 2 of our ICH-GCP R3: What should we expect? Series.  

The R3 builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies and includes provisions for Quality by Design, data driven approaches, integration of modern technology in clinical trials, remote monitoring, the use of electronic informed consent, and advanced risk-based quality management strategies. This enables trial efficiency and participant safety while ensuring data integrity. Additionally, the E6 R3 guidelines outline a more collaborative approach to clinical trials, where roles and responsibilities are shared more clearly between sponsors, investigators, and regulatory bodies. Emphasis is also placed on the need for quality management systems that are adaptable to the growing complexity of trials. With decentralized trials becoming more common, these guidelines will address how to handle new challenges associated with remote data collection, participant engagement, and electronic health records. 

What Learners Need to Focus On 

This ICH GCP Guideline is composed of Principles and, initially, 2 Annexes that expand on the Principles, with specific details for different types of clinical trials. In general, for clinical research professionals, these are the critical areas of change that the R3 guideline addresses:  

  1. Strengthening patient safety: The ICH GCP Principles put emphasis on the requirements to strengthen patient safety throughout the trial. The trial’s conduct and the importance of data collected should be proportionate to the risk to trial participants’ safety.  
  1. Efficient Trial Design: ICH GCP R3 states that the Principles are intended to support efficient approaches to trial design and conduct. For example, innovative digital health technologies, such as wearables and sensors, may expand the possible approaches to trial conduct. 
  1. Enabling Modern Data Governance: The rise of digital health technologies means that learners will need to understand how data is collected, monitored, and managed electronically. This includes a focus on e-source data, such as data from wearables, the secure handling of participant information, and the principles of data integrity. Data governance is an important chapter that was added to the ICH GCP R3 when compared to the R2 Addendum.  
  1. Risk-Based Approach: The R3 guidelines stress the importance of risk-based approaches to trial setup, monitoring and quality management. Learners will need to understand how to evaluate the priorities involved in each trial and the risks associated with the priorities. This will help ensure efficiency by focusing on activities critical to achieving the trial objectives.  
  1. Decentralized Models and diverse patient populations: The use of innovative designs and technology helps to include a more diverse patient population and enables wider participation. Decentralized trials are expected to become more widespread, requiring professionals to be familiar with the requirements for managing remote monitoring, virtual visits, and participant engagement across multiple platforms.  
  1. Electronic Informed Consent: With technology becoming an integral part of the clinical trial process, learners must be knowledgeable about the regulatory requirements for the use of electronic informed consent processes. This includes understanding the ethical and legal requirements, ensuring participant comprehension, and managing consent across various digital platforms. 
  1. Responsibilities in clinical trials: The updated guidelines emphasize that roles and responsibilities in clinical trials should be clear and documented, as in modern trials various service providers and vendors are part of the setup and conduct of the trial.  More emphasis is put on the oversight by sponsors and investigators. ICH GCP R3 also recommends sponsors to consider input from stakeholders like patients and healthcare professionals in the setup phase of the trial.  

How GCP Central’s Innovative Training Supports Learners 

GCP Central offers an interactive and online training platform that is perfectly suited to help learners navigate the complexities of the ICH GCP E6 R3 guidelines. Our GCP R3 training uses real-world scenarios, allowing participants to translate the guidelines and regulations into clinical practices. Through flexible, expert-led courses, learners can engage with updated content at their own pace to learn about the updated Good Clinical Practices guideline. 

To help you get started with mastering the ICH GCP E6 R3 guidelines, we invite you to pre-register for our ICH GCP R3 transition course here: Pre-register for ICH GCP R3 Training. The online modules will be launched in the first quarter of 2025, making sure you’ll know what to expect when the updated version of GCP goes live.  

Adapting to a Changing Landscape 

As clinical trials continue to evolve, professionals must be prepared to meet new challenges and requirements. Through GCP Central’s online GCP training modules, learners gain the necessary knowledge to adapt to these changes in the rules and regulations of clinical research and be compliant with the guideline when setting up or executing clinical trials. By staying informed and continually updating their knowledge, clinical trial professionals can contribute to the success of future trials, maintaining the highest standards of participant safety and data integrity. 

Don’t miss out on the chance to be fully prepared. Pre-register today and stay up to date on the release of our updated ICH GCP R3 training. 

Additional Reading

ICH Assembly Meeting Agenda, 4-5 June 2024 Fukuoka, Japan.  

 Formal ICH Procedure 

Draft Guideline ICH GCP E6 R3 

Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) 

ICH GCP R3: What Should We Expect Part 1 

ICH GCP R3: What Should We Expect Part 2.

ICH GCP R3: Why Innovative ICH GCP Training Matters 

Implementation of ICH GCP (E6) R3: Key Points and Process Overview