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: 

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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 here.  
  • 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: Click here 
  • Training Guidance: Click here 

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:  Click here
  • 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, Division3:  Click here
  • 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:  Click here
  • 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

1. 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. 

2. 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.

c.  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