Regulatory compliance services

To foster and maintain our reputation as a world-class center for clinical research, the CCCR provides and coordinates compliance-related services for clinical researchers offered through the University’s QA and Regulatory Compliance Specialist.  Support is provided in the following areas:

  • Conducting internal regulatory file reviews 

  • Guiding researchers through the regulations and guidelines governing research projects (e.g. University policies, REB SOPs, TCPS2, ICH-GCP, Health Canada, US FDA regulations, etc.)

  • Supporting researchers, who are undergoing inspections from regulatory bodies, such as Health Canada and the FDA

  • Implementing and maintaining N2 Standard Operating Procedures for clinical trials conducted at the University of Calgary.

  • Trial registration with ClinicalTrials.gov 

Service listing:


ClinicalTrials.gov site administration

The International Committee of Medical Journal Editors requires that all clinical trials be registered with an approved registry. In North America, that registry is ClinicalTrials.gov and, to be compliant with Good Clinical Practice (GCP) standards and our university policies, your registration with them is required.  

The CCCR serves as the University of Calgary's institutional administrator for ClinicalTrials.gov, providing researchers and their teams with operational guidance and support with using the website. We offer support with:

  • Creation and maintenance of PI and coordinator account 
  • Study registration
  • Approval of trials added to the site

For help with creating your ClinicalTrials.gov account, please email cccr@ucalgary.ca.                 

How to request study Regulatory Compliance Services:

In order to receive services, researchers must hold an academic appointment at the University of Calgary. Regulatory Compliance Services are offered in coordination with the University’s QA and Regulatory Compliance Specialist. To learn more about these services and to ensure your clinical trial is being conducted to the highest research standards, please contact Linda Longpre at 403.220.6470 or linda.longpre@ucalgary.ca.