If you are a Sponsor/CRO conducting clinical research in both Canada and the U.S., there are important differences between the Canadian Clinical Trial Application (CTA) and the U.S. Investigational New Drug (IND) submission process.

IND Submission Process in the U.S.

In the U.S., once the IND has been submitted for review, the FDA has 30 calendar days in which to determine whether a clinical hold is necessary. If the Sponsor does not hear back from the FDA, on day 31 after submission of the IND, the Study may proceed as submitted once it has been approved by an IRB. A written acknowledgement from the FDA is not always provided. Once an IND application is in effect, the Sponsor is expected to submit Protocol Amendments to the FDA for review prior to implementation. However, a written acknowledgement from the FDA is not required for implementation of the Amendment; the Amendment may be implemented once it has been submitted to the FDA and approved by an IRB (21 CFR § 312.30). If the Sponsor wishes to receive comments regarding a submission from the FDA, a request for such comment – along with the specific questions to be addressed – must be provided at the time of submission.

CTA Submission Process in Canada

The approval process is different in Canada. Once a CTA has been submitted and reviewed, Health Canada notifies the Sponsor within 30 calendar days if the application is found to be acceptable or deficient. If the application is deemed acceptable, a No Objection Letter (NOL) (Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications, section 2.5) is issued by Health Canada. Clinical study activities cannot begin until the NOL has been issued by Health Canada and the Study has been approved by an IRB/REB. The same process applies when there is an Amendment to the Clinical Study Protocol. As per Canadian regulations, the Amendment may not be implemented at any Sites in Canada until Health Canada has issued a new NOL (or an Acknowledgement of Notification for non-substantive modifications to the Protocol). It is the Sponsor/CRO’s responsibility to ensure that no Sites implement the Amendment until Health Canada has issued the new NOL.

Management of Submissions by Veritas IRB

Submissions may be made to Veritas IRB prior to, or concurrently with, submission to the FDA and/or Health Canada. The IRB/REB can approve a clinical trial prior to the end of the 30-day FDA IND review period or the issuance of the NOL by Health Canada. In the latter, however, a note should be included in the IRB/REB’s Approval Form stating that research activities may not begin until the NOL has been issued. The NOL must be submitted to the IRB/REB once it has been issued by Health Canada.
Kayla Antonucci

Kayla Antonucci provides high quality support on ethical review activities. Her educational background includes a Post Graduate Diploma in Regulatory Affairs from the Toronto Institute of Pharmaceutical Technology and a Graduate Diploma in Clinical Research from the Department of Experimental Medicine at McGill University, during which she worked on a clinical research study on the effect of carotid endarterectomy on arterial stiffness. She has also completed a B.Sc. with a major in Physiology from McGill University, and has taken a course in medical writing at Concordia University. // Kayla Antonucci offre du soutien de grande qualité aux activités liés à la révision éthique des projets de recherche. Ses antécédents scolaires incluent un diplôme de cycles supérieurs en affaires réglementaires du Toronto Institute of Pharmaceutical Technology et un diplôme d’études supérieures en recherche clinique de la division de médecine expérimentale de l'Université McGill. Au cours de ce dernier elle a contribué à un projet de recherche portant sur les effets de l’endartériectomie carotidienne sur la raideur artérielle. Elle a également obtenu un baccalauréat en sciences spécialisé en physiologie de l'Université McGill et a suivi un cours de rédaction médicale à l'Université Concordia.