Study Operations & Data Management
Efficient, ethical, compliant research — made simple.
Tools, standards, and guidance to support high-quality clinical studies at every step.
N2 Clinical Research Standard Operating Procedures (SOPs)
Available in English and French | Member Access Only
The 2026 N2 Clinical Research SOPs, available in English and French and launching in mid-February, provide a standardized framework to support ethical, high-quality, and compliant clinical research across Canada, reflecting evolving regulatory requirements and best practices through their biennial updates.
Developed in collaboration with clinical research experts from across the country, N2’s SOPs guide the full lifecycle of clinical research—from study start-up and participant recruitment to data management, monitoring, and study close-out—ensuring consistency, efficiency, and integrity across member organizations.
These SOPs are a key benefit of N2 membership and are available exclusively through the member portal. They should not be shared out of N2.
Highlights:
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Available in both English and French
- Updated every two years to reflect regulatory changes and best practices
- Cover the entire lifecycle of clinical research
- Developed by experts across Canada
- Ensure ethical, high-quality, and compliant research practices
- Support consistency and efficiency across member sites
- Exclusive to N2 members through the member portal
Governing Data and Biological Sample Transfers Agreement (gDSSA)
Available in English | Open Access
The gDSSA is a national, pre-negotiated framework that makes data and sample sharing faster, simpler, and more consistent across Canadian institutions. Developed by the ACT Consortium Contracts Working Group, it reduces administrative burden by using standardized terms and a straightforward transfer letter to capture study-specific details, helping teams move from request to execution with far fewer delays.
Since launching in February 2024, the gDSSA has grown from 29 to 56 signatories, including universities, hospitals, research institutes, and health authorities. It’s especially useful for studies involving secondary use of data or samples, retrospective or prospective chart reviews without consent, and data-only analyses.
To learn more or inquire about becoming a signatory, contact Breanne Stewart (breanne.stewart@micyrn.ca) or Jennifer Cox (jencox@ohri.ca).
Biospecimen-Related SOPs
Available in English | Member Access
High-quality biological specimens are essential to successful clinical trials and research. These SOPs offer a practical, standardized approach to collecting, processing, storing, and distributing biospecimens, helping teams achieve consistent, reliable results across sites and biorepositories.
Developed through a coordinated effort by OICR’s High Impact Clinical Trials (HICT) program and the Ontario Translational Research Network (OTRN), the SOPs address gaps in biospecimen standards and support quality across Ontario’s collection sites. They’re organized into three series (000 – General SOPs, 100 – Biorepository SOPs, 200 – Clinical Trial SOPs) and can be adapted or expanded with additional documents as needed.
Can be adapted locally with additional SOPs, appendices, or tools. Accessible at 3CTN.ca. For general clinical trial SOPs, visit the N2 SOP Portal (members only) or email n2@n2canada.ca.