Clinical Trials – what researchers need to know

If you are conducting a clinical trial at HHS (research involving human participants) there are a number of resources available to assist in either the development of the clinical trial itself, or the negotiation with the appropriate industry sponsor of the clinical trial agreement.

This section of our website will include information on:

–  how and when to register your clinical trial publicly;

–  how and when to apply to Health Canada with a Clinical Trial Application;

–  links to training opportunities, contract negotiation, budget negotiation, ethics approval, and

   opening a research finance account.

The information provided here is presented in two sections: Information pertaining only to Investigator-Initiated Clinical Trials and information helpful for all clinical trials –initiated by either an industry sponsor or an investigator.

Please note that any Industry sponsored clinical trials are subject to a 30% overhead fee.

Information for
Investigator-Initiated Clinical Trials

Information for both Investigator-Initiated
and
Industry-Sponsored Clinical Trials

**Research studies undergoing an external sponsor audit must notify the Research Compliance and Support Services team at the earliest opportunity so that support and resources can be provided to the investigator and/or research team members. In addition, investigators are required to share evidence of study team completed training records (both study-specific and generic) and must submit these to the Research Compliance and Support Services team once available.