Description

The Clinical Trial Site Information (CTSI) form is required to be submitted by clinical trial sponsors prior to initiating a protocol or implementing subsequent amendment(s) at the clinical trial site for trials that are subject to Division 5 of Part C of the Food and Drug Regulations or the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.

Resources

Name	Format	Description	Link
Instructions for completing the Clinical Trial Site Information Form	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/forms/instructions-clinical-trial-information-form.html
Instructions for completing the Clinical Trial Site Information Form	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/formulaires/instructions-formulaire-information-essai-clinique.html

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