An investigator-initiated clinical trial is defined as a research study:
- authored (or provided significant input into the conception and planning), initiated and conducted by a member of the University of Alberta and/or Alberta Health Services/Edmonton Area faculty or staff, and
- not primarily authored, wholly sponsored, nor subject to scientific review, by any for-profit outside entity including, without limitation, a pharmaceutical company or clinical research organization.
If you are conducting an investigator-Initiated Clinical Trial involving off-label use of a drug, device, or biologic, you may need to complete a Health Canada Clinical Trial Application (CTA; which will issue a No Objection Letter (NOL) or Investigational Testing Authorization (ITA), as applicable).
Please contact Quality Management in Clinical Research (QMCR) for further details and assistance with submitting a CTA.
Advisor: Scott Jamieson