Efficient, ethical, compliant research—made simple.

Running a successful clinical study takes more than great science — it requires standardized processes, clear agreements, and compliance at every step.

This section includes standard operating procedures (SOPs), templates, and national frameworks to help you:

  • Promote quality and consistency across research sites with standardized SOPs (English & French | Member Access Only)

  • Use the gDSSA framework to streamline data and biospecimen sharing across institutions (Open Access)

  • Access biospecimen SOPs to support standardized collection, storage, and distribution (Open Access)

These tools reduce administrative burden, accelerate startup, and ensure your study operations are coordinated, efficient, and compliant.

N2 Clinical Research Standard Operating Procedures (SOPs)

Available in English and French | Member Access Only

The 2023 N2 Clinical Research SOPs, available in English and French, provide a standardized framework to support ethical, high-quality, and compliant clinical research across Canada. Updated every two years, they reflect evolving regulatory requirements and best practices.

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:

  • 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
N2 Member Portal

Governing Data and Biological Sample Transfers Agreement (gDSSA)

Available in English  | Open Access

The gDSSA is a national, pre-negotiated framework that
simplifies and accelerates research collaboration across institutions.
Developed by the ACT Consortium Contracts Working Group, it streamlines the transfer of data and biological samples by:

  • Providing standardized terms and conditions to minimize revisions

  • Using a transfer letter to capture study-specific details while preserving the integrity of the core agreement

  • Reducing execution timelines and ensuring a consistent, efficient process

Adoption & Impact

Since its launch in February 2024, the gDSSA has grown from 29 to
56 Canadian signatories, including universities, hospitals, research institutes, and health authorities.

When to Use the gDSSA

Ideal for studies involving:

  • Secondary use of data or samples
  • Retrospective chart reviews
  • Prospective chart reviews (without consent)
  • Data-only analysis

Where Can You Access?

To view the Governing Data Sample Sharing Agreement, click
here.

Interested in Learning More or Joining the Growing List of Adoptees?

Contact Breanne Stewart at
breanne.stewart@micyrn.ca or
Jennifer Cox at
jencox@ohri.ca for details.

Biospecimen-Related SOPs

Available in English | Open Access

High-quality biological specimens are essential to the success of cancer clinical trials and research.  To ensure consistent and reliable analysis of DNA, RNA, and proteins, standardized collection, storage, and distribution procedures are critical.

In the absence of formal regulations governing biospecimen collection and management, shared SOPs provide a practical and effective path to ensure
consistency and quality across research sites and biorepositories.

About the Biospecimen SOPs

Created through a coordinated effort by OICR’s High Impact Clinical Trials (HICT) program and the Ontario Translational Research Network (OTRN). Designed to address the lack of standardized processes across Ontario’s biospecimen collection sites.

Organized into three series:

  • 000 – General SOPs: Apply to clinical trials and biorepositories
  • 100 – Biorepository SOPs
  • 200 – Clinical Trial SOPs

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.