Were you forwarded this email and want in on the latest in clinical research?

ICH E6(R3) - Revised Good Clinical Practice Guidelines

The International Council for Harmonisation (ICH) has revised their guidelines for Good Clinical Practice (GCP). The newest version, E6(R3) Good Clinical Practice (GCP) Guideline was published in January 2025, and builds on the concepts introduced in E6(R2).

While the European Medicines Agency (EMA) has adopted E6(R3) effective July 23, 2025, Health Canada, has not yet announced their adoption timelines, but have indicated that Canadian-specific updates are anticipated in Spring 2026.

Until Health Canada formally adopts E6(R3), the enforceable standard in Canada remains E6(R2).

What does this mean for us?

Don't worry, the CTO is here to help you prepare for these changes to the GCP guidelines.  

N2 Canada has revised their Canada GCP courses to incorporate the new E6(R3) guidelines. Updates to the following courses will be available through CITI, starting on October 27, 2025.

• GCP Basic Course
• GCP Refresher Course 
• Clinical Research Coordinators 

All U of A staff and students can access these training resources by selecting University of Alberta (N2) as their Organization Affiliation, on the CITI registration page. The CTO will provide more information closer to the release of these materials.

We are aware that some industry sponsors are requesting study staff complete E6(R3)-specific training modules, often proprietary to their organizations. These requests can result in duplicative training across multiple trials and sponsors.

The University of Alberta’s position is, as E6(R3) has not yet been adopted in Canada, we will not require or mandate duplicative E6(R3) training for study staff.

Instead, study staff may provide the attached CTO Note-to-File* to sponsors requesting E6(R3) training, which confirms our institutional stance and compliance with current Canadian regulations.

What should we do to prepare?

The CTO will update all study teams once Health Canada provides an adoption timeline for E6(R3). At that time, a harmonized institutional approach to E6(R3) training will be rolled out.

The CTO will be also be sending updates on training sessions and newly available resources as they develop.

Follow along and subscribe to the CTO Connect Newsletter to keep up to date with the launch of E6(R3) at the University of Alberta.

Next Steps

• If a sponsor requests proof of E6(R3) training, please provide them with the attached CTO Note-to-File*.
• Continue to maintain current E6(R2) GCP certification (valid for 3 years).

Optional: consider reviewing the N2 training session to enhance familiarity with E6(R3) changes.

*Access to the U of A CTO Note-to-File E6(R3) Training Requirements, as well as other resources for clinical trials can be requested here. Already a member of the community of researchers? Click here to go directly to the Note-to-File. 

Network of Networks (N2) Canada Training

R2 to R3 Comparison Session Recording

On October 1, 2025 N2 Canada offered a learning session highlighting the key changes from R2 to R3. 

Highlights:

• Understanding ICH E8(R1) as the foundation for E6(R3)

• Defining and applying Critical to Quality (CtQ) factors

• Recognizing Risk Management as a shared responsibility

E6(R3) emphasizes inclusivity, adaptability, and critical thinking—encouraging research practices that reflect today’s evolving, technology-driven environment.

Missed the event, or want to revisit what was covered?

N2 Canada has made the recording of the session available, along with reference material and educational resources. Access to these resources is free for all U of A staff and students, and will be available until 31 December, 2025. 

A Self-Attestation Form for the recorded session is available and can serve as documentation of awareness of the updates from R2 to R3.

View the recorded session here, and request access to the Self-Attestation Form, presentation slides and other resources here. Already a member of the community of researchers? Click here to go directly to the Note-to-File.