Templates

Update November 15, 2024:

1) 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.

2) 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.

TOOLS
QI vs Research screening 
 
CONSENT FORMS   
Adults - Informed consent form templates for clinical trials  (V4.2)English versionFrench version
   
Informed consent form templates for non-interventional research (V4.1)  English versionFrench version
   
Pediatrics - MSSS informed consent form templates for clinical trials and/or multi-centre studiesEnglish versionFrench version
   
Pediatrics - informed consent form templates for other types of studiesEnglish versionFrench version
   
Template for Children's Oncology Group (COG)English versionFrench version
   
Consent form template - BiobankingForthcomingForthcoming
   
MSSS-FRQ Regulatory clausesEnglish versionFrench version  
   
GDPR AppendixEnglish versionFrench version
   
PROTOCOL AND BIOBANK FRAMEWORK 
Biobanking/Registry Management framework templateEnglish versionForthcoming
   
Protocol template for HRR ResearchEnglish versionForthcoming