The Clinical Trials Office (CTO) is pleased to inform the U of A research community that the final five N2 Clinical Research Standard Operating Procedures (SOPs) are now available.

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) 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.

This release of the new Sponsor Conduct SOPs completes the current suite of N2 Clinical Research SOPs. Together, these SOPs represent an important milestone for Canada’s clinical research community. Developed through extensive collaboration and expert review, the complete suite supports high-quality, consistent clinical research practices while allowing flexibility to meet local organizational needs.

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

• Updated Table of Contents (ToC)

Clear delineation between site-based procedures (-000 series) and sponsor-related procedures (-100 series).

• Updated Glossary of Terms

Includes common terms used in clinical trials with detailed definitions.

• Revision Guide

A summary table mapping content from previous versions to the new 2026 series.

• New SOP Quiz

Updated knowledge-check questions for all procedures.

Additional Resources

An FAQ document is included to support implementation and address common questions.

To facilitate documentation of training, the CTO has included a training attestation form for the complete suite of SOPs. 

If you have questions regarding implementation at the University of Alberta, please contact the Clinical Trials Office.

Thank you for your continued commitment to high-quality, compliant, and participant-centered clinical research.

Accessing the New 2026 Version of the N2 Clinical Research SOPs

As an N2 (Network of Networks) member organization, University of Alberta staff and students are eligible to access N2’s updated SOPS at no additional cost.

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