Institution / Investigator Initiated Clinical Trials

This refers to the situation where a clinical trial is not initiated by a commercial sponsor. In this case, the institution / investigator assumes the regulatory responsibilities of a clinical trial sponsor.

What Types of Clinical Trials Must Be Filed

All regulatory requirements for CTAs apply to institution / investigator-initiated clinical trials. The institution / investigator is considered to be the sponsor of the trial for studies that involve:

• the use of a product that is not authorized for sale in Canada
• a product marketed in Canada, where the use of the product in the clinical trial is outside the parameters of the NOC and/or DIN, i.e. one or more of the following is different:
  • indication(s) and clinical use
  • target patient population(s)
  • route(s) of administration
  • dosage regimen(s)

What Information Must Be Submitted to Health Canada

CTAs for these trials should include the same information as for trials with a commercial sponsor (see Clinical Trial Applications), with the following modifications:

Administrative Information

Appendix 3 of the Drug Submission Application Form (HC/SC 3011) may be signed by the appropriate Department Head in lieu of the Senior Executive Officer, and the Qualified Investigator may sign in lieu of the Senior Medical or Scientific Officer in Canada (Appendices 1 and 2 should be completed and submitted if applicable).

Clinical and Quality Information

For drugs not marketed in Canada, the Investigator's Brochure and data on Quality (Chemistry and Manufacturing) must be submitted. If the manufacturer of that product has previously submitted information to Health Canada that meets the regulatory requirements for CTAs, a letter authorizing cross-reference (letter of access) to the information on file may be submitted in lieu of the Investigator's Brochure and/or Quality (Chemistry and Manufacturing) Information.