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 version | French version |
Informed consent form templates for non-interventional research (V4.1) | English version | French version |
Pediatrics - MSSS informed consent form templates for clinical trials and/or multi-centre studies | English version | French version |
Pediatrics - informed consent form templates for other types of studies | English version | French version |
Template for Children's Oncology Group (COG) | English version | French version |
Consent form template - Biobanking | Forthcoming | Forthcoming |
MSSS-FRQ Regulatory clauses | English version | French version |
GDPR Appendix | English version | French version |
PROTOCOL AND BIOBANK FRAMEWORK | ||
Biobanking/Registry Management framework template | English version | Forthcoming |
Protocol template for HRR Research | English version | Forthcoming |