Health Canada Clinical Trial Applications (CTAs)

A Health Canada Clinical Trial Application (also called a CTA, but not to be confused with the Clinical Trial Agreement!) is required when Sponsors (individual, corporate body, institution or organization that conducts a clinical trial)are conducting clinical trials from Phases I-III of drug development. This includes trials involving marketed products where the proposed use of the product is outside the parameters of the approved Notice of Compliance (NOC) or Drug Identification Number (DIN), or one or more of the following is different:

  1. Indication(s) and clinical use;
  2. Target patient population(s);
  3. Route(s) of administration, or;
  4. Dosage regimen(s).

The CTA must be filed before the trial is to start in Canada. The Health Products and Food Branch of Health Canada must review the application and notify the Sponsor within 30 days if the application is found to be deficient, or else the Sponsor may proceed with the trial.

This includes Institutional/Investigator-initiated CTAs. There are some modifications, as outlined in the Guidance for Clinical Trial Sponsors document.  

Questions from staff concerning preparation of a CTA may be addressed to Gita Sobhi, HHS Research Pharmacist, 905.521.2100 x 73447/76019 or sobhi@hhsc.ca.

Review and Signature by the appropriate institutional authority is required before submitting a CTA to Health Canada. The administrative contacts to facilitate this process are:

Hamilton Health Sciences:
Lauren Gogo, Manager of Research Contracts
Hamilton Health Sciences Corporation
120 – 293 Wellington Street North
Hamilton, ON L8L 8E7
PH: 905-521-2100, ext. 44070
EM: gogo@hhsc.ca

McMaster University:
Augusta Beck, Grants Specialist
Health Research Services
McMaster University
Faculty of Health Sciences
1280 Main St. W., Room HSC-3H9
Hamilton, ON L8S 4K1
PH: 905-525-9140, ext. 22465
FX: 905-523-6061
EM: hsresadm@mcmaster.ca

St. Joseph’s Healthcare Hamilton:
Emma Kapetanovic, Research Officer – Regulatory, Quality & Contracts
St. Joseph’s Healthcare Hamilton
St. Joseph’s Charlton Campus
3rd Floor Martha Wing, Room H330
50 Charlton Avenue East
Hamilton, Ontario L8N 4A6
PH: 905 522 1155, ext. 32993
EM: ekapetan@stjosham.on.ca