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Advancing Health Equity Through Innovative Clinical Trials
Advancing Health Equity Through Innovative Clinical Trials
Uplifting communities, fostering inclusivity, and driving innovation in clinical trials
Uplifting communities, fostering inclusivity, and driving innovation in clinical trials
The University of Alberta Clinical Trials Office is the secretariat for University of Alberta Clinical Trials (UACT) and a leader in clinical trials, committed to improving health outcomes through collaboration, innovation, and intentional and meaningful inclusion of historically, and currently excluded populations. Our office supports a diverse range of clinical trials with a focus on reliability, adaptability, efficiency, accountability, and innovation.
Mailing List
Mailing List
Join the community of researchers to keep up to date with the latest news, events, announcements and developments in clincal research.
Announcements
Announcements
N2 2026 SOP Update Now Available
N2 2026 SOP Update Now Available
February 18, 2026
February 18, 2026
The Clinical Trials Office (CTO) is pleased to inform the University of Alberta research community that the Network of Networks (N2 Canada) 2026 Standard Operating Procedures (SOPs) are now available with an official launch date of February 17, 2026.
Clinical research sites are required to operate under SOPs to protect participants, ensure data integrity, and maintain compliance with applicable local, provincial, federal, and international policies, regulations, and guidance. The N2 SOPs provide a single, standardized set of procedures applicable across therapeutic areas and research settings, simplifying adoption and maintenance while supporting regulatory compliance.
The 2026 edition replaces the 2023 version and reflects the most comprehensive review since the SOP program was introduced in 2008. Following Independent Expert Review, terminology and structure have been updated to align with Health Canada’s implementation of ICH E6(R3) (effective April 1, 2026) and to better delineate site-level and sponsor-related responsibilities. The SOPs meet requirements under Health Canada regulations, and align with FDA guidance, ICH-GCP, and TCPS2.
Important Implementation Notes
Important Implementation Notes
The N2 SOPs are issued as print-only PDFs.
Site-level edits or modifications are not recommended, as changes may impact compliance.
Sites may develop supporting tools (e.g., checklists, templates, Operational Notes to File) to align procedures with local practice; however, these tools are not considered official SOP documents.
The SOPs describe how tasks are performed. The rationale (“why”) is addressed through study-specific training.
What’s Included in the 2026 Series
What’s Included in the 2026 Series
Updated Table of Contents (ToC)
Clear delineation between site-based procedures (-000 series) and sponsor-related procedures (-100 series).
Revision Guide
A summary table mapping content from previous versions to the new 2026 series.
New SOP Quiz (Coming Soon)
Updated knowledge-check questions for all procedures.
Additional Resources
Additional Resources
An FAQ document is included to support implementation and address common questions.
Additional SOPs—covering topics such as essential records, investigational medical devices, informed consent, safety assessment, sponsor oversight, monitoring, and audits—are planned for release in the coming months.
If you have questions regarding implementation at the University of Alberta, please contact us.
First time access to the Tools, Templates, and SOPs available through the CTO Clinical Trial Resource Portal can be requested here.
Already have access to CTO Tools + Templates? Click here to login and access the resources including the N2 2026 Series SOPs.
The University of Alberta's Finalized Institutional Position on ICH GCP E6(R3) Implementation
The University of Alberta's Finalized Institutional Position on ICH GCP E6(R3) Implementation
Until April 1, 2026, ICH GCP E6(R2) remains the required and accepted standard for all Health Canada–regulated trials.
Study teams are not required to take both the R2 and R3 courses during this period.
After April 1, 2026, if your R2 certification is still valid, completion of the N2 Comparison Session and Self-Attestation Form demonstrates awareness of the transition and will meet R3 training expectations.
The CTO recognizes and accepts either (a) valid E6(R2) certification with self-attestation and review of the N2 R2 to R3 comparison session, or (b) completion of E6(R3) training.
Although not required if the Self-Attestation Form is signed, the R3 certification is available to anyone who wishes to update to R3.
Please be aware, some Industry sponsors may not accept our Institutional position and will require you to take the new N2 CITI E6(R3) course after April 1, 2026.
If your E6(R2) Certification is
If your E6(R2) Certification is
STILL ACTIVE
STILL ACTIVE
Your Requirement:
You are not required to take the new E6(R3) course until your current certification expires.
Action Plan:
▶️ 1. Watch the N2 "E6(R2) to E6(R3) Comparison Session" recording
🖊️ 2. Sign the N2 GCP E6(R3) Self-Attestation Form.
📂 3. Keep a copy of the signed form in your training file.
If your E6(R2) Certification is EXPIRED or EXPIRING SOON
If your E6(R2) Certification is EXPIRED or EXPIRING SOON
Your Requirement:
Training on the new E6(R3) guidelines is now available through N2 CITI Canada.
Action Plan:
📚1. Recertify under E6(R3) via N2 CITI Canada
📂 2. Keep a copy of the updated certificate in your training file.
Clinical Trials in the News
Clinical Trials in the News
Researchers explore a surprising link that could point to new ways to help people with dyslexia and other reading difficulties.
A 12-week program at the U of A is helping patients with chronic health issues. Watch Dr. Puneeta Tandon, the CTO Clinical Innovation Lead for Digital Health & Translational Solutions, explain the importance of breath work within the EMPOWER trial.
"Kids with broken or sprained limbs don’t need oral opioids to treat their pain, according to newly published findings from a cross-Canada study by pediatric emergency researchers."
Learn more about the work Dr. Samina Ali and her team have been doing to study treatments for pediatric musculoskeletal pain in emergency department across Canada.
Learn about new advances in wearable tech and its applications in lung health from Dr. Giovani Ferrara, the academic lead of the CTO Digital Health Unit.
Dr. Ferrara joins the Unsung Lung Podcast and discusses using AI to predict lung health flare-ups, digital health and its real life applications, and how individual statistics can have population-wide impacts.
Upcoming Events
Upcoming Events
ICTU News
ICTU News
October 24, 2025
October 24, 2025
WCHRI welcomes Tibetha Kemble (Stonechild) as academic lead of Indigenous women’s health research
WCHRI welcomes Tibetha Kemble (Stonechild) as academic lead of Indigenous women’s health research
Honouring distinctions and lived experiences through co-creation
Honouring distinctions and lived experiences through co-creation
Academic Talks and Seminars
Academic Talks and Seminars
The Women & Children's Health Research Institute (WCHRI) hosts regular learning sessions on health research topics. For a full list of upcoming sessions, and recordings of past sessions, visit the events section of WCHR website.
Join WCHRI’s academic lead for Indigenous children's health research, Grant Bruno, for a strength-based Elders’ panel focused on honouring the experiences of residential school survivors and fostering awareness through intergenerational dialogue. Rather than centering trauma, the event will highlight resilience, strength and visions for healing in child health through the voices of Elders.
Date: September 29
Time: 3–4:50 p.m.
Location: ECHA L1-490
Orange Shirt Day Gathering
Orange Shirt Day Gathering
Gender-Inclusive Research Practice
Gender-Inclusive Research Practice
Diversity and inclusion in pediatric research: From ideation to implementation
Diversity and inclusion in pediatric research: From ideation to implementation
The Ethical Engagement of Distinctions-based Indigenous Peoples and Communities in Clinical Research
The Ethical Engagement of Distinctions-based Indigenous Peoples and Communities in Clinical Research
Missed the event, or want to review what you learned? Visit WCHRI's YouTube Channel to learn more.
Indigenous Clinical Trials Unit (ICTU)
Indigenous Clinical Trials Unit (ICTU)
Health inequities among Indigenous Peoples in Canada arise from systemic injustices and require culturally responsive, community-led solutions. The Indigenous Clinical Trials Unit, the first of its kind in Canada, enables and uplifts Indigenous-designed and implemented clinical trial research that addresses the unique needs of Indigenous Peoples and communities while strengthening and promoting sovereignty and self-determination in health research innovation. The ICTU marks a significant step toward rectifying colonial impacts on health and empowering Indigenous sovereignty in healthcare.
Decolonization, Diversity, Equity, and Inclusion in Clinical Trials
Decolonization, Diversity, Equity, and Inclusion in Clinical Trials
Clinical research has immense potential to improve health outcomes for everyone. However, the historical and ongoing legacy of inequities has left
many populations excluded, including Indigenous, racialized,
2SLGBTQIA+ communities, people with disabilities, and others. The Clinical Trials Office (CTO) is committed to identifying and rectifying these inequities and ensuring clinical trials serve all communities with fairness, dignity, and respect.
Digital Health Unit (DHU)
Digital Health Unit (DHU)
Our digital Health Unit harnesses the power of cutting-edge technology and clinical research to create innovative solutions that improve health outcomes and expand access to care and clinical trials. We are at the forefront of exploring how digital tools, such as mobile apps, wearable devices and telemedicine, transform the way clinical trials are conducted and how patients engage with tier care.
We actively collaborate with academic researchers, healthcare innovators, and patients to build strong dynamic partnerships that fuel progress and innovation. From project conception through to data analysis, the Digital Health Unit provides comprehensive support every step of the way.
Territorial Acknowledgement
Territorial Acknowledgement
The University of Alberta, its buildings, labs, and research stations are primarily located on the traditional territory of Cree, Blackfoot, Métis, Nakota Sioux, Iroquois, Dene, and Ojibway/Saulteaux/Anishinaabe nations; lands that are now known as part of Treaties 6, 7, and 8 and homeland of the Métis. The University of Alberta respects the sovereignty, lands, histories, languages, knowledge systems, and cultures of First Nations, Métis and Inuit nations.
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