Do I Need to Submit a CTA?
If your clinical trial is in Phase I through III of drug development or is a comparative bioavailability trial then these CTA requirements apply. If your clinical trial involves marketed products, where the proposed use of the product in your protocol is outside the parameters of approval (Notice of Compliance/Drug Identification Number), e.g. If one or more of the following is different than what’s in the approved product monograph then the CTA requirements also apply:
a. indication(s) and clinical use;
b. target patient population;
c. route(s) of administration;
d. dosage regimen
However, investigators are not required to file a CTA for clinical trials involving marketed drugs where the trial is to be conducted within the parameters of the approved NOC or DIN. These are considered Phase IV trials.