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.
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 GCP training. GCP training must be completed every two years.
Exception: For researchers conducting only retrospective studies without participant contact, only TCPS2 training is required.
To create an account users should go to the CITI website and click on “Register”. The organization affiliation is “Unity Health Providence St. Joseph’s and St. Michael’s Healthcare (N2)”.
It is preferred that you use your Unity Health email address when registering.
When logging in in the future, use the regular “Log In” option (not Log In Through My Organization).
Once logged in, you can find the Division 5 Course by going to My Courses > View Courses. If the course does not appear on this page, there is a link at the bottom of the page to add a course.
The course is called Canada GCP Course: Researchers Involved with Human Research.
There are two CITI courses available for GCP training.
Canada GCP Basic, Stage 1: For researchers involved with prospective human research
This GCP course consists of 10 modules, which are relevant to all researchers conducting human research. These modules focus on the basics of good clinical practice, research ethics boards, essential documents, sponsor responsibilities, investigator responsibilities, informed consent, investigational (drug) product management, adverse and serious adverse event reporting, and monitoring/audits/inspections. This training will expire in 2 years.
Estimated time to complete course: 4.5 hours (approximately 20-30 minutes per module, each followed by a short quiz)
Canada GCP Refresher, Stage 2: For researchers involved with prospective human research and who have already completed the Canada GCP Basic course
This GCP course (Stage 2) reinforces the importance of concepts covered in the Canada Basic GCP course (Stage 1). This course consists of 7 modules that focus on the basics of good clinical practice, investigator and sponsor responsibilities, informed consent, adverse and serious adverse event reporting, handling investigational (drug) products, and monitoring/audits/inspections.
The CITI GCP Refresher (Stage 2) course is only available to those who have completed the CITI Canada GCP Basic (Stage 1) course. CITI will send you an automatically generated email reminder 90 days prior to the expiry of your GCP training, at which time the GCP refresher course will become an available option for you. You will be allowed to take the GCP Refresher course every two years for a maximum of two times.
Estimated time to complete course: 1.5 to 2 hours (approximately 20 minutes per module, each followed by a short quiz)
A mark of 80 per cent is required to pass each of the CITI GCP courses. At the end of the course you will be issued a certificate of completion that you can print or e-mail to yourself for your records.
If you have completed GCP training within the last two years under the affiliation of another organization, a copy of the training certificate must be provided.
Submit external training certificates to the Research Ethics inbox (researchethics@unityhealth.to).
