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 firstname.lastname@example.org to request access to a Phase I ICF template.
|QI vs Research screening|
|ICF templates for clinical trials (Adults) (V4)-ENG and ICF templates for clinical trials (Adults) (V4)-FR||English version||French version|
|ICF templates for Non-interventional research – V4 ENG||English version||Forthcoming|
|Pediatrics-MSSS ICF templates for clinical trials and/or multi-centre 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|