Administrative Contacts for CTAs
Refer to the appropriate administrative contact indicated below for institutional review and signature before submitting your CTA to Health Canada:
For Hamilton Health Sciences:
Ms. Lauren Gogo ,
Manager of Research Contracts Hamilton Health Sciences Research Administration
293 Wellington Street North, Ste. 103
Hamilton, ON L8L 8E7
PH: 905-521-2100, ext. 44070
For Research St. Joseph's - Hamilton:
Mr. Adam Weerdenburg , Research Quality Assurance Officer
Research St. Joseph's - Hamilton
St. Joseph's Healthcare Hamilton
50 Charlton Avenue East
H303 Martha Wing
Hamilton, Ontario L8N 4A6
PH: 905 522 1155, ext. 35280
For McMaster University:
Ms. Caroline Woods , Senior Agreements Officer
Health Research Services
Faculty of Health Sciences
1280 Main St. W., Room HSC-3H9
Hamilton, ON L8S 4K1
PH: 905-525-9140, ext. 22006
Institutional/Investigator-initiated CTA Requirements
The Food and Drug Regulations provide authority to the Health Products and Food Branch (HPFB) of Health Canada to regulate the sale of drugs for the purposes of use in human clinical trials. Division 5 of the Regulations defines specific Clinical Trial Application (CTA) requirements and prescribes a 30-day default review period for these applications. Amendments to Division 5 were announced in June 2001 and took effect September 1, 2001.
Sponsors must file applications to conduct clinical trials in Phases I through III of drug development. This includes applications to conduct clinical 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) application, e.g. one or more of the following is different:
- Indication(s) and clinical use;
- Target patient population(s);
- Route(s) of administration, or
- Dosage regimen(s).
A CTA must be filed prior to the initiation of a clinical trial in Canada. HPFB must review the application and notify the Sponsor1 within 30 days if the application is found to be deficient or else the Sponsor may proceed.
Institutional/Investigator-initiated CTAs must also comply with the same regulatory requirements that apply to sponsor-initiated1 CTAs, with some modification as outlined in the Guidance for Clinical Trial Sponsors document referenced below.
Questions from staff concerning preparation of a CTA may be addressed to Gita Sobhi, HHS Manager of Pharmacy Research Support Services, 905.521.2100 x 73447 or firstname.lastname@example.org.
Health Canada Web Links
The following are links to the web pages where you will find Health Canada News Releases, clinical trial guidance documents and CTA-related forms:
Health Products & Food Branch
Natural Health Products
THERAPEUTIC PRODUCTS DIRECTORATE (TPD)
HEALTH PRODUCTS & FOOD BRANCH INSPECTORATE
NATURAL HEALTH PRODUCTS DIRECTORATE