Completing Module 2 (Amendment)
For investigator-initiated clinical trials, Module 2 is only submitted if the product is not on the market in Canada or if the manufacturer of the product under investigation has not previously submitted information to Health Canada on the quality of this product. A letter of cross-reference from the manufacturer can be submitted in lieu of this module.
If it is necessary to complete this module, please see the Guidance for Sponsors of CTA Quality (Chemistry and Manufacturing), CTA on Health Canada’s website.