Regulatory & Monitoring Services

The Clinical Trials Office at the University of Alberta is committed to supporting researchers in conducting high-quality, compliant, and participant-focused clinical trials. Our services are designed to navigate the complexities of regulatory requirements and ensure rigorous, yet pragmatic, monitoring throughout the study lifecycle.​

Regulatory Affairs Support

Our Regulatory Affairs team provides comprehensive assistance for clinical trial submissions to Health Canada, including:​

• Preparation and submission of Clinical Trial Applications (CTAs) and Investigational Testing Authorizations (ITAs)
  
  

• Guidance on amendments, notifications, and safety reporting
  
  

• Liaison with Health Canada
  
  

• Ensuring compliance with national regulations and international guidelines​
  
  

We offer unmatched expert advice and support to facilitate effective and efficient approval processes.​

Clinical Trial Monitoring Services

Our Monitoring Services are designed to maintain the integrity of clinical trials by:​

• Conducting routine site visits to assess compliance with the protocol and regulatory requirements

• Reviewing informed consent processes and documentation

• Ensuring accurate and complete data collection

• Ensuring timely, accurate, and complete recording and reporting of adverse events

• Identifying and addressing any issues promptly to protect participant safety​
  
  

By providing ongoing oversight, we help ensure that trials are conducted ethically and that data collected is reliable and valid.​

Benefits of the CTO Services?

Partnering with the CTO means benefiting from:​

• Expertise in navigating regulatory landscapes
  
  

• Commitment to participant safety and data integrity
  
  

• Support throughout the trial, from initiation to completion
  
  

• Alignment with best practices and ethical standards​
  
  

Our goal is to facilitate the successful execution of clinical trials that contribute valuable insights to the medical community while upholding the highest standards of research conduct.​

For more information or to access our services,