Investigators
Tools and Templates for Clinical Trials
To support the design and conduct of clinical trials, the CTO provides a broad suite of tools, templates & resources.
Training and Development Opportunities
Educational opportunities aimed at enhancing the skills and knowledge of research personnel are available through the CTO.
CTO Connect Newsletter + Archive
The CTO provides updates on clinical trial news, events, guidance documents and other useful resources via CTO Connect.
Protocol Development
Interventional and observational protocol templates are available from the CTO to aid researchers in outlining their studies, and we are available for consultation on the methodology, feasibility, etc.
Budget Development
The CTO is available for consultations on study budgets and can direct you to relevant development resources.
Research Team Support
Our team can provide you with consulting services, strategic plan templates, advice, and mentorship to help you independently run your study.
Health Canada Applications
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.
Study/Site Coordination
The CTO can assist you with your study setup, ethics submission, consent form development, requesting resources and more.
Participant Recruitment
For investigators or units that require recruitment support, the CTO is available to provide experienced clinical trial coordination on a cost-recovery basis.
Tools & Templates
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.
Clinical Trial SOPs
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.
Electronic Data Capture
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.
Study Registration
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.
Training
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.
Data & Safety Monitoring Board (DSMB) Support
We can provide you with a DSMB charter template and support you with the logistics.
Clinical Trial Monitoring / Quality Assurance
The CTO provides risk-based clinical trial monitoring for all Health Canada–regulated studies that are sponsored by the University of Alberta.
Record Archiving
The CTO can arrange for long-term storage of investigator-initiated clinical trial documents to satisfy the 15 year retention requirements from Health Canada.
Site Feasibility
We can assist you with feasibility questionnaires and arrange qualification tours of our site facilities.
Budgets
The CTO is available for consultations on study budgets and can direct you to relevant development resources.
Research Team Support
Our team can provide you with consulting services, advice, and mentorship to help you independently run your study.
Study/Site Coordination
We can assist you with your study setup, ethics submission, participant recruitment and enrollment, study conduct, and more.
Indigenous Clinical Trials Unit (ICTU)
The ICTU, the first of its kind in Canada, enables and uplifts Indigenous-designed and implemented clinical trials that address the unique needs of Indigenous Peoples and communities while strengthening and promoting sovereignty and self-determination in health research innovation.
Digital Health Unit (DHU)
The DHU supports the design of robust, digitally enabled clinical trials by incorporating tools such as wearable devices and mobile data collection. We provide expert guidance on selecting & integrating digital health tech, including apps, wearables and telehealth, ensuring seamless implementation within research protocols.