Research training should be completed by anyone conducting, or is involved in, research at Osler in accordance with the ethical and regulatory guidelines.
This includes 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 Osler (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.
Copies of research training should be submitted with your Initial REB Application or Change in Study Personnel form to WOHSREB@williamoslerhs.ca. It is the Investigators responsibility to ensure required training is kept up to date for the study members at all times.
What training do I need to complete?
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.
Good Clinical Practices (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
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.
How do I know what training I need for my study type?
All individuals conducting research at Osler require TCPS2. If your study will involve human participants, GCP is also required. Individuals involved in clinical drug trials requiring Health Canada authorization will need their HCD5 training.
Links to training websites