Our team can provide you with consulting services, strategic plan templates, advice, and mentorship to help you independently run your study.

Studies involving “off-label” uses of marketed drugs, natural health products, devices, biologics, or new products or devices may fall under Health Canada regulations. The CTO can assist with submissions to Health Canada for regulatory approvals.

The CTO can assist you with your study setup, ethics submission, consent form development, requesting resources and more.

For investigators or units that require recruitment support, the CTO is available to provide experienced clinical trial coordination on a cost-recovery basis. 

The CTO provides a suite of templates to facilitate your trial. These tools have been developed by industry experts and field tested for regulatory compliance and applicability at the U of A.

As a member of N2, a full suite of Health Canada and FDA-approved SOPs are available to all U of A and Alberta Health Services staff. 

The electronic data capture system REDCap is licensed by the U of A for internal use and is provided free of charge to U of A researchers. In collaboration with the REDCap team, the CTO is available to aid the development of a REDCap project for your trial.

The CTO is the U of A's administrator for the public trial registry Clinicaltrials.gov. We can issue account credentials and provide assistance with registration of your trial.

As a member of N2, training courses in Good Clinical Practice, Health Canada Division 5 regulations and other research topics are available to U of A researchers. 

We can provide you with a DSMB charter template and support you with the logistics.

The CTO provides risk-based clinical trial monitoring for all Health Canada–regulated studies that are sponsored by the University of Alberta.

The CTO can arrange for long-term storage of investigator-initiated clinical trial documents to satisfy the 15 year retention requirements from Health Canada.