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 St. Michael’s Hospital human research activities (i.e., any involvement at the St. Michael’s Hospital site, on behalf of St. Michael’s Hospital, with St. Michael’s Hospital participants/charts/identifiable data, etc.) are required to complete GCP training
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 St. Michael’s Hospital 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 three courses different courses available for GCP training. Read the descriptions below to see which course you are required to take:
This option is for researchers who are engaged in clinical trial research with investigational products (i.e. drugs, biologics, medical devices). The full CITI Canada GCP Stage 1 course consists of 13 modules providing training in good clinical practice.
The full course encompasses applicable regulations governing human research in Canada including Health Canada-Division 5, the Tri-Council Policy Statement 2, the U.S. Food and Drug Administration (U.S. FDA), and the International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines. The full course includes the regulations involved in conducting clinical trials with investigational products.
Estimated time to complete course: 6 to 7 hours (approximately 30 minutes per module, each followed by a short quiz)
Note: this includes human biological materials; they may be conducting clinical trials but not with investigational products
For those researchers conducting human research (including human biological materials) but not engaged in clinical trials with investigational products, the GCP course consists of 7 modules, which are relevant to all researchers conducting human research. These modules focus on the basics of good clinical practice, investigator obligations, informed consent, adverse events, and audits/inspections.
Estimated time to complete course: 3 to 4 hours (approximately 30 minutes per module, each followed by a short quiz)
In April 2015, CITI released the GCP refresher course (Stage 2) that 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 responsibilities, informed consent, adverse events, investigational product (drug) management, audits/inspections/monitoring and sponsor responsibilities.
The CITI GCP Refresher course is only available to those who have completed the CITI Canada Basic GCP (Stage 1) course within the past three years. 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 and 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 completed the CITI GCP course under a different affiliation (i.e., you did not choose St. Michael’s Hospital as your institution) or you have completed equivalent GCP training within the last two years, please email your training certificate to Dina Coronios (CoroniosD@smh.ca) in the Office of Research Administration so that we can manually update our training records.