Templates

Update May 21, 2025:

1) Use Protocol Template: A new template is now available for research projects that use data and/or samples that are already stored in a research biobank. The template is aligned with Québec’s regulatory context and seeks to facilitate the submission and institutional authorization of such projects.

2) Differentiation Tool: A new version of the tool for distinguishing between research, quality assurance (QA), and quality improvement (QI) is now available. This updated version reflects the regulations currently in effect in Quebec.

Update February 20, 2025:

3) Health Records Research (HRR) Protocol: A general update to the protocol template based on the latest policies and guidelines.

Update November 15, 2024:

4) Clinical trials (adults): The Informed Consent Form (ICF) template for clinical trials has been updated to reflect the coming into effect of the Act respecting health and social services informationon July 1, 2024. The changes include clarifications to the Confidentiality section. In addition, some of the wording in the template has also changed to increase inclusivity. A version highlighting these changes is available [here] for reference. 

Effective immediately, the updated English and French versions (V4.2), linked below, must be used for all clinical trials not yet approved.

5) Pediatric research: New versions of the Informed Consent Form (ICF) templates (English and French) for pediatric research are now available. The changes made reflect the coming into effect of the Act respecting health and social services informationon July 1, 2024.

Effective immediately, these updated templates, linked below, must be used for pediatric research projects not yet approved.

For any question about the ICF templates, please contact [email protected]. 

Early clinical phase:

Considering that Phase I studies present a lot of particularities, researchers should either create a tailored consent form or carefully adapt available templates to accurately represent the study. Researchers can send an email to [email protected] to request access to a Phase I ICF template.