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 Fall 2025.

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

What does this mean for us?

Worry not, the CTO is here to help you prepare for these changes to the GCP guidelines.  

Training on E6(R3) guidelines is not yet available through CITI, however they are reviewing the finalized guidelines and will update their training courses accordingly. 

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.

Optional Training Opportunity

As an N2 (Network of Networks) member organization, University of Alberta staff and students are eligible to attend N2’s upcoming education session outlining the key changes between E6(R2) and E6(R3).

This is an optional way to update your awareness of the changes without retaking the CITI Canada GCP course before your current certificate expiry.

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 attending 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

Virtual | 12:00 - 1:00PM MDT

The release of ICH E6(R3) is approaching, and we’re updating the N2 CITI Canada GCP Basic and Refresher courses to align with the new guidance.

This session will:

✔ Highlight key changes between R2 and R3

✔ Offer a way for some organizations to update training without requiring learners to retake the GCP course before expiry (institutional decision)

✔ Provide attendance confirmation certificates for both live and recorded viewing

💡 Whether you’re a learner, site lead, or administrator, we’ve got your back with:

• Updated courses launching this fall
• Clear timelines to help you plan
• Live and recorded education sessions

Attendance confirmation certificates will be available for live viewing (session will also be recorded).

All U of A staff and students can access this session by selecting University of Alberta as their N2 Member organization, on the registration page