CCCR's Monitoring Services
CCCR’s Mandatory Monitoring Service
As of November 1st, 2026, CCCR’s monitoring service is mandatory for all new Health Canada-regulated investigator-initiated clinical trials (IITs). This ensures that every regulated IIT receives consistent, independent, and GCP-compliant oversight throughout the life of the study.
Monitoring is an essential component of GCP and is required under Health Canada’s adoption of ICH E6(R3) standards. Implementing an institutional monitoring program provides important advantages:
- Identifies issues early and supports timely corrective actions
- Strengthens data integrity and participant protection
- Promotes audit readiness and regulatory compliance
- Provides consistent standards across all investigator-initiated trials
- Reduces administrative burden and variability for research teams
Eligibility
- All new Health Canada-regulated Investigator-Initiated Trials (IITs), sponsored by the Governors of the University of Calgary
- Studies submitted to the Quality Assurance Office for Clinical Trial Application (CTA) or Investigational Testing Authorization (ITA) review on or after the mandatory implementation date.
CCCR Monitoring Program Fee
Monitoring fees shall be assessed using an institutional risk assessment conducted during study intake and start-up. Each study will be assigned a risk category that determines the amount of monitoring to be provided and the associated annual monitoring fee.
The fee structure is intended to:
- Support sustainable delivery of monitoring services
- Provide transparent and predictable budgeting for investigators
- Ensure monitoring resources are proportionate to institutional and study risk.
FAQ's
Monitoring is an essential element of study conduct designed to ensure ethical conduct, proper collection and documentation of study results, appropriate records of study procedures and subject interactions, and compliance with the approved protocol. Monitoring ensures the protection of participants' rights and safety, as well as the integrity and quality of the resulting data.
The extent of monitoring is determined by a risk-based approach. Per ICH E6, “the purposes of trial monitoring are to ensure:
a) The rights, safety and well-being of human subjects are protected.
b) The reported trial data are accurate, complete, and verifiable from source documents.
c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s)."
Risk Assessment & Monitoring Plan
The Quality Assurance office will conduct a risk-assessment and, in conjunction with the Sponsor-Investigator, prepare a detailed monitoring plan tailored to the needs of the trial.
Monitoring Qualifications
A monitor with appropriate training and qualifications will be assigned to your study.
Initial Initiation Visit
An initial monitoring visit will take place after the site has completed all regulatory requirements and has obtained all approvals. The visit will include review of the essential documents, record management and recruitment plans.
Interim Visits
Using the protocol and approved monitoring plan, the monitor will periodically review the following in a risk proportionate manner:
- Confirmation of eligibility
- Documentation of informed consent
- Protocol adherence
- Data collection and quality
- Source documentation review
- Study drug/device management and accountability
- Adverse event review and compliance with reporting obligations
- Compliance with sponsor-investigator obligations
Close-out Visit
The close-out visit will ensure all the necessary aspects of the study have been addressed by the study team prior to close out and archiving.
We encourage teams to contact us early in the development of the project so we can provide advice on risk management strategies and budget development.
Who should I contact?
To discuss your study’s monitoring needs, please contact cccrmonitoring@ucalgary.ca
What if I already have a monitor for my studies?
This mandate does not apply to currently active Health Canada-regulated investigator-initiated studies so you may continue to follow your established monitoring processes. For any future studies, you will be required to use the CCCR monitoring service.
Is this service available to non-regulated and/or externally sponsored studies?
Yes. This service is optional for any study that does not meet the requirements for mandatory use. The same fee structure will apply so we encourage you to reach out to us in the early stages of protocol development.
Questions & Get Started
For questions about monitoring and to get the monitoring process started, email cccrmonitoring@ucalgary.ca.