Drug clinical-trial sponsor: prepare and file the regulatory application with Health Canada
Classify the trial, assemble protocol, quality and clinical records, obtain ethics and sites, then manage amendments and incidents.
No person should be recruited or exposed to the product before applicable regulatory and ethics authorizations and site activation.
Confirm the scope
Define the sponsor, product, indication, phase, population, protocol, comparator, importation, manufacture and Canadian sites.
Prepare the information
Assemble forms, brochure, protocol, consent, clinical and non-clinical data and chemistry-manufacturing records in the required format.
Complete the process
File the application, answer clarification requests and obtain research-ethics approval and information for every site.
Keep follow-up records
After authorization, control product, consent, monitoring, incidents, amendments, suspension, closure and record retention.
Clinical Trial Applications — Health Canada