Phase I to III natural health product trial: obtain the notice of authorization before the first participant
Phase I to III natural health product trial: obtain the notice of authorization before the first participant
Research ethics approval alone does not allow the trial to start. Each site must be ready and the sponsor must obtain written regulatory authorization.
Confirm the scope
Confirm the product, investigational use and phase fall under the natural health product regulations and identify the sponsor.
Prepare the information
Prepare the protocol, brochure, consent, quality data, synopsis, sites, investigators, ethics board and safety information.
Complete the process
Complete the application and attestation, site forms and undertakings, then submit the electronic package through the current channel.
Keep follow-up records
Await the authorization notice and ethics approvals, then manage amendments, reactions, records, inspection and result disclosure.
Natural health product clinical trial forms — Health Canada