Does my clinical trial or study require Health Canada approval? 

While this question is essentially outside the scope of these support pages we thought it might be helpful to offer some guidance.

A Clinical Trial Application (CTA) must be submitted to Health Canada for any clinical trial involving human subjects where the product (drug, herbal product, medical device, etc) is either not approved for use in Canada or is being used outside of the terms of it's existing approval.

For specific information please see the Health Canada Web site and/or consult the University of Alberta's Quality Management in Clinical Research group (QMCR).

WCHRI can provide additional support and advice for investigators performing a study that is being performed under a Health Canada CTA and who are therefore required, by law, to comply with division 5 of Canada's food and drug regulations. Specifically these regulations require that investigators comply with the principles of ICH GCP. These require, but are not limited to:

• Investigators are required to establish, maintain and follow standard operating procedures (SOPs)

  • The University of Alberta suggests that investigators use the N2 SOPs

• Data collection applications/software must be "validated"

  • WCHRI maintains a seperate installation of REDCap for studies performed under a CTA

• All aspects of study conduct must be subject to appropriate quality control (study monitoring and data management).

  • WCHRI can provide advice and resources to help with database build and data management. Investigators who are not WCHRI members should contact the University's QMCR group for advice.