On January 6, 2025, the (ICH) adopted the new . The next step for the ICH members is to implement the new guideline in their respective countries or area of authority. Health Canada has confirmed that ICH E6(R3) will come into effect on April 1, 2026.
GCP re-training is mandatory for researchers, research team members and others (if applicable) conducting clinical trials at Queen’s University, Kingston Health Sciences Centre-Research Institute (KHSC-RI), and Providence Care as there are changes in GCP Guideline.
By definition of the , a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials.
Mandatory training requirements
1. GCP: update to ICH E6(R3)
All Qualified/Principal Investigators, research team members and others (if applicable) conducting clinical trials are required to complete or update their GCP — or other ICH E6(R3) Training — before April 1, 2026. In the event this is not possible, a note file is required to clarify the reasons for the delay, and completion should be done as soon as possible thereafter.
Please note, due to the global nature of clinical trials, some Sponsors may require updated GCP training prior to Health Canada’s implementation on April 1, 2026.
- If you are taking GCP for the first time or you receive your notification to retake your GCP (Basic or Refresher) before April 1, 2026:
- Complete the current CITI Canada GCP course, which includes the E6(R3) updates
- Receive a new completion ‘certificate’ and ‘report’
- If your GCP training is not due to expire before April 1, 2026 and you don’t receive a notification to retake your GCP, re-complete your previously taken GCP course (which will include the R3 updates) and receive an updated completion ‘report’. Follow these steps:
- Log in to your CITI account
- Under ‘Institutional Courses’, select ‘View Courses’
- Under ‘Completed Courses’, select ‘Review Course’ for your last GCP course
- Select ‘Review’ next to each module you would like to re-complete. You may see only ‘Review’ buttons or ‘Review’ buttons mixed with blue ‘Start’ buttons. Complete only the ones with blue ‘Start’ buttons
Make sure you have completed the correct modules
At the end of each CGP module, to confirm you are in a E6(R3) module, certify the "Most recent" column indicates "October 2025" (see the image).
Please note, re-completing modules does not change or extend the Learner certificate’s expiration date.
A Part 2 of your Completion Report or Coursework Transcript will be generated to reflect the most recent completion date and score for each module and contain updated language confirming alignment with ICH E6(R3) for re-completed modules under ‘Description’, as indicated in yellow highlight:
This GCP training contains all of the attested CITI Program modules from the Good Clinical Practice (GCP) – Canada Version 3. This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
2. ICH E8(R1): general considerations for clinical studies
Due to the importance of for the implementation of ICH E6(R3), the review of will also need to be completed by April 1, 2026.
As there is no completion certificate generated to confirm the review of the above video, you will need to self-attest to this training.
Please use this to capture this training for your records.
Questions?
If you have questions regarding the transition to E6(R3), please contact your local research administration: