ICH-GCP E6(R3) : Do you need a new team training ?

The latest revision of the ICH-GCP E6(R3) guideline for clinical trials requires your team members get updated  training. Clinical research is a fast-evolving field, with high-stakes ramifications. For a future-ready team, enroll them in a refresher clinical research training course that covers the vital changes to the standard.

What is ICH-GCP E6(R3)?

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released an January 2025 update to Good Clinical Practice (GCP) guideline number E6, covering the design, conduct , recording, and reporting of clinical trials that involve human participants.

The original goals of the guideline are to protect the rights, safety, and well-being of clinical research participants trial, while producing high-quality, credible data.

That said, the field of clinical research is dynamic, with changes that affect core aspects of running successful studies. Decentralized clinical trials, advances in technology, new design and management principles, and the transforming roles and interactions between clinical trial sponsors and investigators, are some of the changes addressed in the ICH-GCP E6(R3) update released in January, 2025.

Is ICH-GCP training mandatory?

Yes and for good reason. Regulatory agencies like the FDA (USA), EMA (EU), and MHRA (UK) require organizations to demonstrate compliance with the latest ICH-GCP standards. That’s why annual, documented GCP training is not just recommended, it’s expected. Many clinical trial sponsors even go further, enforcing stricter internal training policies for high-risk studies, outsourced partners, and global trials.

ICH-GCP isn’t just a guideline, it’s the backbone of ethical, high-quality clinical research. It ensures that trials are scientifically robust, globally standardized, and trusted by regulators worldwide. That’s why compliance isn’t optional: it’s embedded into national laws and required for both trial approvals and the acceptance of your data.

Whether you’re dealing with staff turnover, preparing for an audit, or investing in your team’s professional development, staying up to date with GCP training is essential.

Top 5 changes that are driving the need for updated training

Getting your team ICH-GCP E6(R3) training in the first place ensures your clinical trials are compliant, produce high-quality data, and protect patients. A training refresher course now, given the revision in the standard, is just as important. For organizations conducting or supporting clinical trial research, the move from R2  to R3 is an opportunity. Updated training supports your team’s ability to perform as clinical research continues transforming. Here are the top 5 changes:

1. Integrating Quality by Design

• What’s new: Stronger focus on building quality into trial design from the start.

• Why it matters: Trial staff need to understand how QbD affects protocol development, risk assessments, and operational execution.

• Training need: Teams must be trained on QbD principles and their role in implementing them effectively.

2. Adopting risk-based strategies

• What’s new: Expanded expectations for proactive risk identification, mitigation, and documentation.

• Why it matters: All stakeholders, including site staff and monitors, must understand their role in a risk-based environment.

• Training need: Retraining on RBM (Risk-Based Monitoring) and centralized monitoring is now essential.

3. Updated roles and responsabilities

• What’s new: Clearer delineation of responsibilities between sponsors, CROs, and investigators, especially in outsourced models.

• Why it matters: Misunderstandings here can lead to non-compliance and regulatory findings.

• Training need: Retrain teams to align with new definitions and documentation responsibilities.

4. Integrating technology

• What’s new: Expanded expectations for oversight of electronic systems and service providers.

• Why it matters: With the rise of ePRO, eConsent, and decentralized trials, staff must be fluent in digital system validation and data integrity.

• Training need: Immediate training in system validation, data traceability, and vendor qualification processes.

5. Data Governance and Integrity Requirements

• What’s new: Stronger emphasis on ALCOA+ principles, data transparency, and secure access.

• Why it matters: Ensuring the integrity of digital data is now a team-wide responsibility.

• Training need: Retrain on 21 CFR Part 11 principles, audit trails, and secure access control

What to look for in refresher ICH-GCP E6(R3) training

Refresher training that focuses on the implications of the ICH-GCP E6(R3) update will make your team more efficient and adaptable and make your organization truly future-ready. Even in a refresher, the training should revisit:

✅ Essential Documents : Updates to what’s considered essential under R3.
✅ GCP Principles: The 13 core principles of ICH-GCP.
✅ Roles & Responsibilities: Of sponsors, investigators, monitors, IRBs/IECs.
✅ Informed Consent: Including updates if any in documentation or processes.

Choosing your training partner is highly important. Some advantages to look for include finding an accredited course with a platform that is 21 CFR PART 11 compliant, up to date, and that is globally recognized.

The GxP Training ICH-GCP E6(R3) Refresher is fully online and self-paced to make training convenient and easier to fit into busy schedules. It is specially designed to:

• Keep learners engaged and motivated
• Enhance focus
• Make it easy to take in and retain knowledge
• Boost completion rates
• Compliance : thanks to a 21 CFR PART 11 compliant platform

Train yourself or your entire team with ease by bundling this course with other essential modules. As a team leader, you’ll have access to our seamless dashboard where you can manage enrollments, track progress, and stay on top of certification status . Our certificates are traceable and audit-ready. Interested for you or your team ? Let’s get in touch.