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Transition from ICH GCP E6(R2) to E6(R3): What You Need to Know

As part of our continued commitment to supporting a pragmatic approach to excellence and compliance in clinical trials, the University of Alberta Clinical Trials Office (CTO) is providing updated guidance on Good Clinical Practice (GCP) training requirements during the transition from ICH E6(R2) to ICH E6(R3).

The new ICH E6(R3) guideline was finalized in January 2025, with Health Canada’s adoption expected on April 1, 2026. Until that date, E6(R2) remains the required regulatory standard for all Health Canada–regulated clinical trials.

To help our research teams stay both compliant and practical, the CTO has developed a Note-to-File* outlining a flexible and supportive position and approach for maintaining GCP certification now through Canada’s adoption of E6(R3).

What This Means for You

If your GCP E6(R2) certification has expired or will expire soon, you have two options:

Option 1:

• Recertify under E6(R2) (CITI Canada or equivalent)

• Watch the N2 “E6(R2) to E6(R3) Comparison Session” (More details below)

• Sign the N2 GCP E6(R3) Self-Attestation** Form

You will not be required to take the full E6(R3) course until your next renewal date (three years after your R2 recertification).

Option 2:

• Watch the N2 “E6(R2) to E6(R3) Comparison Session”

• Sign the Self-Attestation Form**, and

• Take the E6(R3) course when it becomes available on October 27, 2025

If Your E6(R2) Certification Is Still Active

You do not need to take the new E6(R3) course yet if you:

• Watch the N2 Comparison Session, and

• Complete the Self-Attestation Form**

If desired, you may take the full E6(R3) course at anytime, however, you will not be required by the University to take it until your next renewal date (three years after your R2 recertification) regardless of Health Canada’s adoption expected on April 1, 2026.  Having said that, some Industry sponsors may not except our Institutional position and will require you to take the new N2 CITI E6(R3) course after April 1, 2026.

The University of Alberta’s Institutional Position

• ICH GCP E6(R2) remains valid and acceptable until April 1, 2026

• Study teams are not required to take both the R2 and R3 courses during this period

• Completion of the N2 Comparison Session and Self-Attestation Form demonstrates awareness of the transition and will meet R3 training expectations

• Although not required if the Self-Attestation Form is signed, the R3 certification is available to anyone who wishes to update to R3

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.

*The full Note-to-File: Transition from ICH GCP E6(R2) to E6(R3), 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. 

**Please retain a copy of the signed Self-Attestation Form in your training file once completed.

If you have any questions, please don’t hesitate to reach out to the CTO team here.

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, and have access to the CTO resource portal? Click here to go directly to the resources.