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.
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.
All GCP training courses can be found on the Collaborative Institutional Training Initiative (CITI) program website.
The first time you access the CITI website, you will need to create an account. Be sure to set your institutional affiliation to “Providence St. Joseph’s and St. Michael’s Healthcare (N2)” when prompted so that our training records are automatically updated.
You can pause and return to the training course if necessary. Just be sure to remember your username and password so that you can log back in and resume the course. For ease of access, you may wish to bookmark the website.
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:
Dina Coronios (Dina.Coronios@unityhealth.to), Office of Research Administration (ORA)