Research Training Requirements
Research training is mandated for anyone who conducts, or is involved in, human research activities at Unity Health Toronto.
About Research Training Requirements
Research training is mandated for anyone who conducts, or is involved in, human research activities at Unity Health Toronto.
Training in, and implementation of, accepted ethical and regulatory guidelines in human research helps to ensure that studies are conducted according to the highest ethical, scientific and safety standards.
All individuals (e.g., investigators, coordinators, and any other personnel conducting research activities including students, trainees, fellows, etc.) involved in conducting human research activities at Unity Health Toronto (i.e., any involvement at a site, on behalf of a site, with site participants/ charts/ identifiable data, etc.) are required to complete mandatory research training depending on the type of research being conducted.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Conducting research according to Good Clinical Practice (GCP) provides public assurance that the rights, safety and well-being of human research participants are protected and that the study data are credible.
The Tri-Council Policy Statement (TCPS-2) is a Canadian guideline for the ethical conduct of research involving humans and/or human biological materials. Training in the Tri-Council Policy Statement (TCPS-2) helps to ensure the ethical conduct of research involving humans.
Health Canada’s Food and Drug Regulations (FDR), Part C, Division 5 applies to all clinical drug trials requiring Health Canada authorization. Part C, Division 5 regulations stipulate the application for authorization, amendments/notifications and sponsor obligations.
Frequently Asked Questions
Training Modules
Good Clinical Practice (GCP)
Frequency: every two years
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
The Canada GCP Course: Researchers Involved with Human Research course can be found on the Collaborative Institutional Training Initiative (CITI) program website.
*This link will take you to the CITI home page. For information on account creation, logging in, and finding and completing the course, please see the FAQs below.
Training Modules FAQ
Tri-Council Policy Statement 2 (TCPS2)
Frequency: needs to be completed only once
The Tri-Council Policy Statement (TCPS2) is a Canadian guideline for the ethical conduct of research involving humans and/or human biological materials.
Note: In 2022, an updated TCPS 2 course was released. This new course will be required for any Unity Health research staff who have not previously completed TCPS 2 training and are involved in human subjects research. Completion of this course is recommended for research staff who have completed the previous version.
Access the TCPS2 course
TCPS2 FAQ
Health Canada Division 5
Frequency: every two years
Training in Part C, Division 5 of the Food and Drug Regulations is a Health Canada required expectation. Given this, Unity Health Toronto has mandated training in Division 5 for anyone involved in conducting research activities for Health Canada regulated clinical drug trials at Unity Health.
The Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects course can be found on the Collaborative Institutional Training Initiative (CITI) program website.
Access the Health Canada Division 5 – Drugs course
*This link will take you to the CITI home page. For information on account creation, logging in, and finding and completing the course, please see the FAQs below.
Health Canada Division 5 FAQ
Responsible Conduct Research (RCR)
Frequency: needs to be completed only once
The Responsible Conduct of Research (RCR) course reviews research topics such as avoiding research misconduct, mentorship responsibilities, handling of data and responsible authorship. This course is not mandatory however it is highly recommended for anyone involved in research.
The Responsible Conduct of Research (RCR) – Life Science course can be found on the Collaborative Institutional Training Initiative (CITI) program web.
*This link will take you to the CITI home page. For information on account creation, logging in, and finding and completing the course, please see the FAQs below.
RCR FAQ
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