Quality Assurance and Education

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) 2022 
Describes the standards and procedures for governing research involving human participants

Application: All research studies submitted to the Sunnybrook research ethics board must be conducted in compliance with the TCPS

The provisions of the Ontario Personal Health Information Protection Act (PHIPA) 2004

Establishes rules for the collection, use and disclosure of personal health information that protect the confidentiality and the privacy of individuals with respect to that information

Application: All research studies submitted to the Sunnybrook research ethics board must be conducted in compliance with the Ontario PHIPA.

A Guide to the PHIPA 2004 (PDF)

Gives health information custodians (HIC) a basic understanding of how the PHIPA applies in the course of day-to-day activities and help HIC understand their rights and obligations under the legislation

Application: The interpretation of PHIPA in this guide should not be relied upon as a substitute for the legislation.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice, E6(R2)

Provides a unified standard to facilitate the mutual acceptance of clinical trial data by the regulatory authorities

Application: All clinical trials filed with Health Canada or the Food and Drug Administration (FDA), and phase IV trials (i.e., post-marketing), must comply with ICH GCP.

Part C (Drugs) Division 5 (Drugs for Clinical Trials Involving Human Subjects) of the Food and Drug Regulations 2001

Defines specific clinical trial application (CTA), and clinical trial application amendment (CTA-A) requirements for the sale and importation of drugs for use in human clinical trials in Canada

Application: All clinical drug trials filed with Health Canada must comply with part C division 5.

Guidance Document (GUI-0100): Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects”

This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in human subjects in Canada to comply with Part C, Division 5 of the Food and Drug Regulations and to understand the International Council for Harmonisation (ICH) Guidance Document: Good Clinical Practice in the Canadian context.  

Guidance Document (GUI-0043): Risk classification guide for observations related to inspections of clinical trials of human drugs

This guide describes how inspectors classify clinical trial inspection observations based on risk and how the overall rating is assigned to an inspection, when applicable, and includes situations that may result in a non-compliance (NC) rating.  It promotes consistency in assigning risk ratings of inspection observations and in the overall inspection rating and also provides examples of inspection observations. 

Part 4 (Clinical Trials Involving Human Subjects) of the Natural Health Products Regulations 2003

Defines specific clinical trial application (CTA) and clinical trial application amendment (CTA-A) requirements for the sale and importation of natural health products for use in human clinical trials in Canada

Application: All clinical natural health product trials filed with Health Canada must comply with part 4.

Part 3 (Medical Devices for Investigational Testing Involving Human Subjects) of the Medical Devices Regulations 

Defines specific investigational testing authorization (ITA) requirements for the sale and importation of class II, III and IV medical devices for use in human clinical trials in Canada

Application: All clinical medical device trials filed with Health Canada must comply with part 3.

International Organization for Standardization (ISO) Clinical investigation of medical devices for human subjects – Good clinical practice 2020 (ISO 14155)

Addresses good clinical practice for the design, conduct, recording and reporting of clinical trials that assess the safety or performance of a medical device.

Application: All clinical trials of medical devices conducted at Sunnybrook and filed with Health Canada or the Food and Drug Administration (FDA) must comply with ISO 14155.

Note: Access to this document is restricted by copyright license. Contact Quality Assurance and Education for user access and more information.

The Personal Information Protection and Electronic Documents Act (PIPEDA) 2000

Rules for the collection, use and disclosure of personal health information that protect the confidentiality and the privacy of individuals with respect to that information

Application: Although Ontario has its own privacy laws, PIPEDA continues to apply to personal information in inter-provincial and international research studies submitted to the Sunnybrook research ethics board.

1. Interagency Panel on Research Ethics (PRE)
   Promotes high ethical standards of conduct in research involving humans through the development, evolution, interpretation and implementation of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS)
   
2. Canadian Institutes of Health Research (CIHR)
   Canada’s major health funding agency that is committed to promoting health research that meets the highest standards of excellence and ethics
   
3. Natural Sciences and Engineering Research Council of Canada (NSERC)
   Helps make Canada a country of discoverers and innovators for the benefit of all Canadians by supporting basic university research, project research and advanced training of highly qualified people
   
4. Social Sciences and Humanities Research Council (SSHRC)
   A federal agency that promotes and supports university-based research and training in the humanities and social sciences through grants and fellowship programs that allow researchers to explore, invent and develop deep expertise in a wide variety of disciplines, and target research to specific social needs
   
5. Health Products and Food Branch (HPFB) – Health Canada
   Takes an integrated approach to managing the health-related risks and benefits of health products and food (home of the Therapeutic Products, Biologics and Genetic Therapies, and Natural Health Products Directorates)
   
6. Pharmaceutical Drugs Directorate (PDD), formerly Therapeutic Products Directorate (TPD) – Health Canada
   Canada’s regulator of prescription pharmaceutical drugs for human use
   
7. Biologic and Radiopharmaceutical Drugs Directorate (BRDD) – Health Canada 
   Regulates biological drugs (products derived from living sources) and radiopharmaceuticals for human use
   
8. Natural and Non-Prescription Health Products Directorate (NNHPD) – Health Canada
   Regulates natural health products for human use
   
9. Network of Networks (N2)
   A national initiative that brings together multiple existing disease networks, several academic institutions and other stakeholders willing to join forces to enhance Canada’s research capability and capacity
   
10. Toronto Academic Health Science Network (TAHSN)
    A dynamic consortium of the University of Toronto and its affiliated academic hospitals to serve as a leader in Canadian health care by developing collaborative initiatives that optimize, advance and sustain a shared academic mission of high quality patient care delivery, education, knowledge transfer and research innovation

Mandatory Clinical Research Training

All research involving human participants and or human materials being conducted within or on behalf of Sunnybrook, must meet current scientific, regulatory, and ethical standards for the protection of human research participants. In order to promote the highest quality, ethical and compliant conduct of research, completion of the following training courses is required for all researchers (depending on research type) and their associated research personnel prior to conducting human participant research.

Sunnybrook’s training requirements (outlined below) have been endorsed by the TAHSN Research Committee with the goal of aligning training across TAHSN institutions.  

Required Training by Research Type

Title	TCPS2 /Basic Biomedical/Social & Behavioral Research	ICH-GCP	N2 SOPs	Food & Drug Regulations Part C, Division 5	Natural Health Product Regulations Part 4	Food & Drug Regulations Part C, Division 3	Medical Device Regulations Part 3	ISO 14155
All Human Participant Research	X	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Interventional Clinical Trials	X	X	X	N/A	N/A	N/A	N/A	N/A
Health Canada Regulated Drug Clinical Trials	X	X	X	X	N/A	N/A	N/A	N/A
Health Canada Regulated Natural Health Product Clinical Trials	X	X	X	N/A	X	N/A	N/A	N/A
Health Canada Regulated Positron- Emitting Radiopharmaceutical Clinical Trials	X	X	X	N/A	N/A	X	N/A	N/A
Health Canada Regulated Medical Device Clinical Trials	X	N/A	X	N/A	N/A	N/A	X	X

TCPS2 or Basic Biomedical or Social & Behavioral Research

• Applicable to all research involving human participants and or human materials regardless of study type
• Options (see Online Tutorials below for links):
  • Tutorial for the Tri-Council Policy Statement (TCPS2: CORE-2022) Course on Research Ethics (no expiry)
    • CORE-2022 has been updated.  Please note, the institution does not require re-training on CORE-2022 for Researchers/Research Staff/REB members who have previously completed the original CORE training. See our FAQ.
  • Basic Biomedical – CITI Canada online  (no expiry)

Good Clinical Practice

• Applicable to all interventional clinical trials involving human participants (may include drugs, biologics, natural health products, medical devices as well as other interventions such as surgery), in addition to above course.
• Good Clinical Practice (GCP) – CITI Canada online (see Online Tutorials below for links): 
  • An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
  • 3 or 5 year expiry (as per sponsor or funder requirements)

N2 Standard Operating Procedures (N2 SOPs)

• Applicable to all interventional clinical trials involving human participants (may include drugs, biologics, natural health products, medical devices as well as other interventions such as surgery), in addition to above courses.
• N2 SOPs
  • The N2 SOPs are a national standardized set of operating procedures that are applicable to any therapeutic area in any given institution or research environment
  • N2 SOPs
  • Training Guidance

Food & Drug Regulations, Part C, Division 5 – Drugs for Clinical Trials Involving Human Participants

• Applicable to Health Canada regulated drug clinical trials, in addition to courses as specified in the training chart
• Health Canada Division 5 – CITI Canada Online (see Online Tutorials below for links):
  • 5 year expiry

Natural Health Product Regulations, Part 4 – Clinical Trials Involving Human Participants

• Applicable to Health Canada regulated natural health product clinical trials, in addition to courses as specified in the training chart
• Training is to be completed and documented as a read and review of the NHP Regulations, Part 4
  • 5 year expiry

Food & Drug Regulations, Part C, Division 3 – Positron-Emitting Radiopharmaceuticals (PERs)

• Applicable to Health Canada regulated PERs clinical trials, in addition to courses as specified in the training chart
• Training is to be completed and documented as a read and review of the PERs Regulations, Part C, Division 3
  • 5 year expiry

Medical Device Regulations, Part 3 – Medical Devices for Investigational Testing Involving Human Participants

• Applicable to Health Canada regulated medical device clinical trials, in addition to courses as specified in the training chart
• Training is to be completed and documented as a read and review of the MD Regulations, Part 3
  • 3 or 5 year expiry (as per sponsor or funder requirements)

ISO 14155 – Clinical Investigation of Medical Devices for Human Participants – Good Clinical Practice

• Applicable to Health Canada regulated medical device clinical trials, in addition to courses as specified in the training chart
• Training is to be completed and documented as a read and review of the International Standard:
  • Contact the Human Research Protections Program (HRPP) to request access to the International Standard:  hrpp@sunnybrook.ca 
  • 3 or 5 year expiry (as per sponsor or funder requirements)

HRPP tracks completion of the applicable training courses for each Principal Investigator (PI) and Qualified Investigator (QI) (where applicable for Health Canada regulated clinical trials).

Institutional authorization to proceed with new or ongoing research project(s) will be tied to course completion. It is the responsibility of the PI/QI to ensure research personnel listed on the REB submission and/or Task Delegation Log have completed all applicable training prior to their study involvement.

Online Tutorials

• The TCPS 2 (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) Tutorial Course on Research Ethics (CORE-2022)
  • CORE-2022 provides an applied approach to the guidance provided in TCPS 2. This self-paced course is a media-rich learning experience that features interactive exercises and multi-disciplinary examples. It will consist of nine modules and a knowledge consolidation exercise (KCE) of 25 multiple-choice questions. To receive a CORE-2022 Certificate of Completion, users will be asked to take the nine modules and successfully complete the KCE.
• CITI Canada On-line Educational Program
  • Sunnybrook Health Sciences Centre is a member of the Networks of Networks (N2). This membership provides access to a variety of resources including the following online courses:
    • Good Clinical Practice (13 modules)
    • Good Clinical Practice Refresher (7 modules)
    • Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects (5 modules)
    • Responsible Conduct of Research (12 modules – 7 required for certificate)
    • Basic Biomedical (9 modules – 8 modules required for certificate)
    • Transportation of Dangerous Goods (TDG) and IATA (6 modules)
    • Social and Behavioral Research Course (11 modules – 10 required for certificate) 
    • Clinical Research Coordinator Course (13 modules – 11 required for certificate)
  • All staff, affiliates and registered students working with human research participants or their data at Sunnybrook are encouraged to complete the online courses. Completion of the course(s) can be done at your own pace and you will need to receive an aggregate mark of 80% to successfully complete each course. Once you have successfully completed a course, a link will be provided to access a certificate for your records.
  • Note: When creating your personal account with the CITI Program, please ensure you select Sunnybrook Health Sciences Centre as the affiliated Canadian Institution and use your Sunnybrook/SRI email address.
• Network of Networks (N2) Education Courses – Dual Code Online
  • N2 is a not-for-profit incorporated organization providing a common platform for sharing best practices, resources and research-related content to ensure efficient and high-quality research, integrity of clinical practices and accountability. N2 has developed clinical research courses as recommended training for the N2 community including:
    • Cultural Competency Skills in Clinical Research (*free under Sunnybrook’s N2 membership)
    • Foundations of Privacy in Research (*free under Sunnybrook’s paid purchase)
    • Medical Devices (*learner’s paid purchase required)
    • Source, CRFs and Good Data Management (*free under Sunnybrook’s N2 membership)
  • Instructions for accessing the courses on Dual Code Online (PDF)

ACRP- Introduction to Clinical Trials (Free course)

This free program provides fundamental education about the role clinical research plays in advancing medical knowledge and the work conducted by clinical research professionals.

The course details how medical products are developed, how volunteer patients are protected, and who plays key roles in the development, research, review, and approval of medical products. The one-hour online program also explores how historical studies have laid the path for creation, revision, and enforcement of the ethical principles and guidelines governing today’s clinical trials.