ASK JEAN: Do I Need Documented Training on Division 5?
25 October 2021
Is it necessary to train and document training on Division 5 Part C (Health Canada Food and Drug Regulations) if you are working in Clinical Trials but have already trained in GCP?
Yes. Qualified Investigators and delegated Clinical Trial research team members at Canadian sites are required both to train and document the training on applicable Health Canada Regulations AND ICH Good Clinical Practice.
Training on Division 5 Part C of the Food and Drug regulations would be necessary if you are part of the research team working on a Phase I to Phase IV clinical trial with an investigational product such as a biologic, radiopharmaceutical, or pharmaceutical. If you are working with a different investigational health product such as a medical device, cannabis, natural health product, controlled substance, or combination product, there are other regulations that would be necessary to train on.
Of note, Health Canada filed two Interim Orders pertaining to regulations related specifically to Clinical Trials and Division 5 during the COVID-19 pandemic. These apply to both medical device and pharmaceuticals. The interim orders are comprehensive and were in effect from May 27, 2020 to May 2, 2021 and the second annex Interim Order 2 from May 3, 2021 to current date (at time of this publication). Research teams are expected to have trained and documented training on the Interim Orders as re-training. Re-training is always necessary if there are changes to the regulations, and such is the case. For further information on other orders and guidance, see the Health Canada.
Clinical Trial Research teams are expected to have trained and documented training on the Interim Orders.
Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 – Canada.ca
ARCHIVED Interim Order respecting clinical trials for medical devices and drugs relating to COVID-19 – Canada.ca
The International Council for Harmonization (ICH) E6R2 Good Clinical Practices (GCP) guidance is also a baseline document adopted by Health Canada. Research team members working on Clinical Trials across product lines are required to train and document training on this document. The requirement for training on the both the regulations and good clinical practice is specified in Health Canada’s Guidance (GUI-0100) Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” which was published in August 2019.
Clinical Trials BC currently provides access for health authorities, universities and their affiliated community sites to the accredited CITI GCP and Division 5 training through its support and funding of a provincial Network of Network (N2) membership.
Interested persons should contact their institutional training representative or Clinical Trials BC at firstname.lastname@example.org for information on access or your representative.