Templates

Update April 20, 2022:

1) Clinical trials (adults): The Informed Consent Form (ICF) template for clinical trials has been updated to reflect the change in the retention period for clinical trials records under the under the Food and Drug Regulations and Natural Health Products Regulations (Health Canada), which came into effect February 11, 2022. Effective immediately, the new English and French versions (V4), available below, must be used for all new clinical trials.

2) Pediatric research: New versions of the ICF templates (English and French) for pediatric research are now available. The ICF templates (English and French) for pediatric research funded by the Children's Oncology Group (COG) have also been updated. The total number of ICF templates for pediatric research has been reduced.

3) Non-interventional research: A new version of the ICF for non-interventional research is available. A French version should be made available shortly.

Additional templates are under development and should be available here in the near future – including French and English versions for Biobanking.

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.