Ethical, compliant, and transparent research—built on strong governance.

Responsible clinical research starts with clear ethical standards and regulatory compliance. At N2, we provide tools and frameworks to help organizations navigate complex requirements while protecting participants, ensuring transparency, and upholding the highest ethical principles.

This section includes guidelines, SOPs, and frameworks to help you:

  • Navigate Canadian regulatory and ethics requirements
  • Standardize REB processes for consistent, high-quality reviews
  • Make ethical decisions at every stage of research
  • Reduce administrative delays with clear, pre-approved agreements
  • Build trust with participants, partners, and the public
  • Proactively manage risk and strengthen quality oversight systems

Whether you’re establishing new processes or refining existing ones, these resources will help you conduct research that is compliant, ethical, and trusted.

Research Ethics Board (REB) SOPs

Available in English and French | Open Source

REB Standard Operating Procedures (SOPs) were collaboratively developed by N2 and CAREB-ACCER to provide a standardized, Canadian framework for Research Ethics Boards (REBs) that review health sciences research. These SOPs are compliant with Canadian and U.S. regulatory and ethics guidance criteria and are available open access in both English and French.

They support the distribution, adoption, and maintenance of a single national standard for REBs in Canada, helping to streamline processes, improve consistency, and uphold the highest ethical standards.

Key features:

  • Collaboratively developed by N2 and CAREB-ACCER.

  • Compliant with Canadian and U.S. regulatory and ethics guidance criteria.

  • Available in English and French via open access.

  • Designed for REBs reviewing health sciences research.

  • Maintained as print-only PDFs to ensure compliance and integrity.

  • Updated as needed, based on urgency and relevance of proposed changes.

Access the N2/CAREB-ACCER REB SOPs
N2/CAREB-ACCER REB SOPs Index

Foundational Documents:

  • Glossary of Terms

  • References

100 – General Administration:

  • SOP 101: Authority and Purpose

  • SOP 102: Research Requiring REB Review

  • SOP 103: Training and Education

  • SOP 104: Management of REB Office Personnel

  • SOP 105A: Conflicts of Interest – REB Members and REB Office Personnel

  • SOP 105B: Conflicts of Interest – Researcher

  • SOP 105C: Conflicts of Interest – Organization

  • SOP 106: Signatory Authority

  • SOP 107: Use and Disclosure of Personal Information

  • SOP 108: Standard Operating Procedures Maintenance

  • SOP 109: Addendum for US Regulated Research

200 – REB Membership:

  • SOP 201: Composition of the REB

  • SOP 202: Management of REB Membership

  • SOP 203: Duties of REB Members

  • SOP 204: REB Office Personnel Serving as REB Members

300 – REB Operations:

  • SOP 301: REB Submission Requirements and Document Review

  • SOP 302: REB Meeting Administration

  • SOP 303: Document Management

400 – REB Review Processes:

  • SOP 401: Delegated Review

  • SOP 402: REB Review Decisions

  • SOP 403: Initial Review Criteria for REB Approval

  • SOP 404: Ongoing REB Review

  • SOP 405: Continuing Review

  • SOP 406: Research Completion

  • SOP 407: Suspension or Termination of REB Approval

  • SOP 408: Course-Based Review

500 – Special Circumstances:

  • SOP 501: REB Review During Publicly Declared Emergencies

600 – Communication:

  • SOP 601: Communication with Researchers

  • SOP 602: Communication with Research Participants and the Public

700 – Consent:

  • SOP 701: Free and Informed Consent

 

800 – Researcher Responsibilities:

  • SOP 801: Researcher Qualifications and Responsibilities

900 – Compliance & Quality Assurance:

  • SOP 901: Quality Assurance Activities

  • SOP 902: Non-Compliance

Please note: Modifying the formal SOPs may affect compliance. SOPs are provided as print-only PDF documents to maintain integrity. Updates are issued as needed, based on the urgency and relevance of proposed changes.

For questions or feedback, contact the REB SOP Chair Dorothy Herbert, via n2@n2canada.ca. 

Observational Health REB SOPs

Available in English | Open Source

Observational Health SOPs were developed for Research Ethics Boards (REBs) that do not normally review regulated clinical trials and therefore are not required to comply with more prescriptive standards and regulations. They are intended for REBs that review non-clinical trial biomedical research, population and global health research, socio-behavioural research, and other studies involving human participants, such as scholarship on teaching and learning, management, and humanities.

Key features:

  • Based on the CAREB/N2 SOPs and compliant with TCPS only.

  • Flexible in style, allowing institutions to adapt them while maintaining TCPS compliance.

  • Future guidelines will address topics such as methods of consent, privacy legislation, and conflicts of interest.

Access the Observational Health SOPs

Questions or suggestions? Contact Rachel Zand at rachel.zand@utoronto.ca.

 

Regulatory Agencies & Key Guidelines

Navigating clinical research in Canada requires an understanding of the regulatory agencies, key guidelines, and ethical frameworks that govern the conduct of trials. Health Canada oversees the regulation of drugs and medical devices, adopting internationally recognized standards like ICH-GCP and enforcing national ethics guidance such as the Tri-Council Policy Statement (TCPS 2). The resources below link directly to the primary regulations, policies, and guidance documents that shape clinical research in Canada.

Health Canada

Health Canada is the Canadian regulatory agency responsible for overseeing drug and device development in Canada.


📎 Health Canada – Division 5
 – Regulations for clinical trials involving drugs.


📎 Health Canada ICH-E6 (Good Clinical Practice)
 – Canada has adopted the ICH-GCP guidelines for the conduct of clinical trials.


📎 Health Canada ICH-E6 (Good Clinical Practice)
 – Canada has adopted the ICH-GCP guidelines for the conduct of clinical trials.

Medical Devices


📎 Health Canada Medical Devices Regulations
 – Requirements for the licensing, sale, and investigation of medical devices in Canada.

Tri-Council Policy Statement (TCPS 2, 2022)


📎 TCPS 2
 – Ethical Conduct for Research Involving Humans, guiding all human research in Canada.

The U.S. Food and Drug Administration (FDA)

The FDA is the U.S. regulatory agency responsible for overseeing drug and device development in the United States.


📎 FDA Laws, Regulations, Policies, and Procedures for Drug Applications
 – U.S. regulations for drug development and clinical trials.


📎 FDA Device Advice: Comprehensive Regulatory Assistance
 – Guidance and regulations for medical device development.

Quality and Risk Management Tools

Available in English and French | Member Access Only

A suite of member-only tools to support risk management, audit preparedness, and quality improvement in clinical research environments. Developed by the N2 Quality Committee, these resources help research teams proactively identify and address risk, build robust quality systems, and align internal processes with Health Canada and ICH E6(R2/R3) expectations.

Risk Management Tools

These tools help institutions and research teams identify, assess, and mitigate potential risks at both the study and institutional levels. Aligned with ICH E6(R2/R3), they support proactive quality practices and regulatory compliance.

Includes:

  • Institutional-Level Risk Management Tool
    Supports broad organizational risk planning, including process gaps and oversight challenges.

  • Study-Level Risk Management Tool
    Focuses on protocol-specific risks such as participant safety, data integrity, and site variability.

  • Statement – Tools and Templates
    A guidance document explaining how to implement and interpret the risk tools.

Quality Management System (QMS) Templates

These QMS resources support the development and evaluation of institutional quality frameworks. They are especially valuable for teams building or refining internal SOPs, oversight processes, and continuous improvement plans.

Includes:

  • QMS Institutional Gap Analysis Tool
    A diagnostic tool for assessing current QMS practices and identifying areas for improvement.

  • Research QMS Overview
    A summary document outlining core QMS principles and components for research settings.

Audit & CAPA Tools

These tools help institutions plan internal audits, classify quality assurance findings, and implement Corrective and Preventive Action (CAPA) plans. They are useful for inspection preparedness and ongoing quality oversight.

Includes:

  • CAPA Plan Template
    A structured form for documenting root causes, corrective steps, timelines, and follow-up.

  • QA Findings Classification Guide
    Standardized categorization of audit findings to promote consistency across sites.

  • Audit Plan Template
    Helps research teams scope and prepare for internal audits.

  • Monitoring Checklists (3 total): 

    • Regulatory

    • Investigational Product

    • Participants

      Each checklist supports real-time monitoring of critical research domains.

Health Canada Inspection Guidance

Available in English | Member Access Only

These member-only tools help research teams prepare for Health Canada inspections, align with regulatory expectations, and respond effectively to audit findings. Developed by the N2 Quality Committee, the documents include detailed guidance on inspection processes, corrective action planning, and real-time tools for study teams.

Full Guidance Documents

These tools help institutions and research teams prepare for Health Canada inspections by providing step-by-step guidance, checklists, and planning resources. They support regulatory compliance, audit readiness, and corrective action planning in alignment with Health Canada expectations and Good Clinical Practice (GCP) standards.

Includes:

  • Health Canada Inspection Guidance (2023)
    Outlines key Health Canada inspection procedures and expectations. Developed by N2 to support institutional and site-level readiness.

  • Inspection Process Document (2015)
    Step-by-step explanation of the inspection workflow used by Health Canada at the time of publication.

  • Inspection Checklist (2015)
    A tool to help study teams self-audit against Health Canada’s compliance areas prior to inspection.

  • CAPA Guidance Document
    Supports development of Corrective and Preventive Action plans in response to inspection findings.

  • Health Canada Reference Summary
    A quick-reference list of relevant Health Canada guidance sources compiled by N2.

Quick-Reference One Pagers

These concise reference tools support on-the-ground readiness during Health Canada inspections. Designed for fast access and clarity, they help research teams stay aligned with regulatory expectations around delegation, protocol deviations, and training documentation.

Includes:

  • Delegation Logs
    Outlines expectations for tracking study responsibilities and qualifications during inspections.

  • Protocol Deviations
    Quick-reference on identifying, documenting, and reporting deviations in compliance with regulations.

  • Training
    Summarizes what Health Canada expects to see related to staff training records during inspection.

Cannabis Research Compliance Tools

Available in English | Member Access Only

These tools support researchers and institutions conducting cannabis-related research in Canada. Developed to align with Health Canada’s requirements for cannabis licenses and Good Production Practices, these checklists and templates help ensure compliance across study startup and monitoring.

Includes:

  • Cannabis Application Checklist (Individual Licence)
    A step-by-step checklist to help institutions and investigators apply for a Health Canada licence to conduct cannabis-related research. Covers documentation, facility requirements, and submission tips.

  • Monitoring Checklist – Cannabis Licence
    Used to assess ongoing compliance with cannabis licence requirements during research. Helps ensure adherence to storage, access control, security, and record-keeping standards.

  • Roles & Responsibilities – Cannabis Licence
    Outlines the responsibilities of key personnel listed on a cannabis research licence, including the Senior Person in Charge (SPIC), Head of Security, and Responsible Persons in Charge (RPICs).

  • Sources: Good Production Practices (2022)
    Provides references to Health Canada’s Good Production Practices (GPP) that apply to cannabis research facilities. Supports compliance with sanitation, environmental controls, and product handling guidelines.

Privacy Guidance Documents

Available in English | Member Access Only

These resources provide foundational guidance on privacy and confidentiality in health research settings. They help ensure compliance with federal and provincial legislation such as PHIPA, and support REBs and investigators in applying privacy best practices throughout the study lifecycle.

Includes:

  • OHA Hospital Privacy Toolkit
    Developed by the Ontario Hospital Association, this toolkit provides detailed guidance for hospitals and research institutions on protecting personal health information. It includes sample policies, risk assessment tools, and breach response strategies.

  • PHIPPA FAQs
    A summary of frequently asked questions about the Personal Health Information Protection Act (PHIPA), focusing on how Ontario’s health privacy legislation applies to clinical research contexts.

  • Privacy in Research Guidance Document
    Outlines principles and best practices for protecting participant privacy in research settings, including data collection, storage, retention, and disclosure procedures.

  • GUI-0100-v1 (Health Canada Privacy Guidance)
    This Health Canada guidance document explains the regulatory expectations related to privacy and confidentiality during clinical trial inspections and oversight activities.

  • Privacy References Summary
    A compiled list of relevant Canadian privacy laws, regulations, and institutional guidelines that impact clinical research, compiled to support compliance and quick reference.

N2 Rapid Response Team

Whitney Duff – Clinical Research Lead, ZYUS Life Sciences Inc. (Co-Chair)
Jean Smart – Regulatory Affairs and Quality Officer, Clinical Trials BC (Co-Chair)

Strengthening Research Governance

N2’s Rapid Response Team is a national group of experienced research and regulatory professionals who act quickly to provide feedback on proposed policy, regulatory, and program changes. By representing the collective expertise of our members, the team helps ensure that new regulations and guidelines reflect the realities of clinical and observational research in Canada.

Their work supports ethical, compliant, and participant-focused research by:

  • Responding rapidly to consultations from Health Canada and other stakeholders.

  • Providing input that protects research integrity while reducing administrative burdens.

  • Ensuring member perspectives are heard in decisions that shape Canada’s research environment.

In 2024, the team:

  • Submitted 7 formal responses to Canadian regulatory policy consultations.

  • Drew on the expertise of 11 quality and regulatory professionals representing a wide range of member types, geographies, and therapeutic areas.

  • Addressed topics including Health Canada’s proposed drug and device regulations, the new clinical trials database, and the ICH E6(R3) draft guideline.

Initiative to Streamline Clinical Trials (ISCT)

Available in English | Open Source

In response to the 2011 Canadian Cancer Research Alliance (CCRA) report on the State of Cancer Clinical Trials in Canada, the Initiative to Streamline Clinical Trials (ISCT) was launched in 2012. The CCRA report identified critical threats to oncology clinical trials, including increasing regulatory burdens, declining performance metrics, and unsustainable complexity. It urged collaboration with Health Canada and other stakeholders to clarify interpretations of the Food and Drug Regulations and ICH Good Clinical Practice (GCP) guidelines.

The ISCT Working Group—comprising clinical trial experts from across Canada—developed a set of practical, regulatory-compliant recommendations aimed at improving efficiency and feasibility in academic clinical trialsinvolving drugs and biologics. These recommendations were finalized in February 2014 and are publicly available to support investigators, institutions, and research teams.

2017 Survey Findings:

To assess the uptake and impact of the recommendations, a national survey was conducted in spring 2017. A total of 75 responses were collected from clinical research professionals across
eight provinces and 34 therapeutic areas.

Adoption

Many sites had already implemented several ISCT recommendations or had practices in place that aligned with them.
However, inconsistent uptake was noted, largely due to uncertainty about Health Canada’s stance on the guidelines.

Impact

Respondents reported reduced time, improved quality, and greater efficiency in several areas, including:

  • CTA and safety reporting
  • Monitoring
  • Equipment and facilities
  • Drug accountability
  • Trial cost

Barriers

The most frequently cited barrier was lack of formal endorsement by Health Canada.
Respondents expressed concern that inspectors might reject ISCT-based approaches during audits.
Additional challenges included institutional resistance, limited awareness, and insufficient resources for implementation.

Access and Use

The ISCT Recommendations are available to all investigators and institutions. You’re encouraged to:

  • Share the link to the recommendations with your teams and networks
  • Include them on institutional websites
  • Participate in annual impact surveys to help evaluate adoption and effectiveness

The recommendations are summarized in a downloadable table, with additional tools and checklists provided for select topics.

To contribute feedback or request implementation support, contact the ISCT Working Group.

Access the Report