On July 30, 2014, Health Canada announced that the Office of Clinical Trials of the Therapeutic Products Directorate (TPD) will cease issuance of ‘Acknowledgement of Notification’ letters for Clinical Trial Application Notifications (CTA-Ns) on September 1, 2014.

What does this mean for your clinical trial?

First off, this change applies only to clinical trials involving drugs being conducted under Part C, Division 5 of the (Canadian) Food and Drug Regulations under a Clinical Trial Application (CTA). This affects primarily Phase I to III clinical trials for which Health Canada issues a No Objection Letter (NOL). This change in process does not affect device trials being conducted under an Investigational Testing Authorization (ITA) from Health Canada.

Second, bear in mind that once a Clinical Trial Application (CTA) has been authorized (and the NOL has been issued), any changes to the clinical study protocol and/or drug supplies must be submitted to Health Canada; these modifications must be submitted as either an Amendment (CTA-A) or a Notification (CTA-N). This process change applies only to CTA-Ns, the second category below:

Amendment (CTA-A)

A CTA-A is required for any changes to a clinical trial that:

  • affect the selection, the criteria for selection, monitoring, or dismissal of a research participant
  • affect the evaluation of the clinical efficacy of the drug
  • alter the risk of harm to the health research participants
  • affect the safety evaluation of the drug
  • extend the duration of the clinical trial

Notification (CTA-N)

A CTA-N would involve any other changes not covered by a CTA-A such as:

  • Information on site closure or completion of the clinical trial
  • affect the evaluation of the clinical efficacy of the drug
  • Discontinuation of a clinical trial or site for non-safety related issues
  • Updated Investigator’s Brochure

What will be considered an official proof of receipt of a CTA-N by Health Canada?

Health Canada has stated that any method indicating receipt may be considered to be the ‘official receipt of a CTA-N being received by the regulator’. This would include fax receipts, recipient’s signature receipt or proof of delivery by registered mail or courier.

Why is Health Canada making this change?

Health Canada has stated that there’s no regulatory requirement for the Office of Clinical Trials to issue ‘Acknowledgement of Notification’ letters for Clinical Trial Application Notifications (CTA-Ns). Despite this lack of any regulatory requirement, the Office of Clinical Trials has been acknowledging about 4,500 CTA-Ns each year.

This change in practice is being implemented in order to reduce the administrative burden on not only Health Canada but also on Sponsors, CROs, research centres and REB/IRBs.

Additional information is available from Health Canada.

The Veritas IRB Inc. Editorial Board

The Veritas IRB Editorial Board covers questions of research ethics, clinical trial conduct, and human research participant protection primarily for sponsors, CROs and investigators/researchers. // Le blogue de Veritas IRB aborde des questions de l'éthique de la recherche, de la bonne conduite des essais cliniques, et de la protection des participants à la recherche dans une perspective axée sur les promoteurs de la recherche, les organismes de recherche sous contrat (ORCs ou CROs), et les chercheurs.