Monitoring Services

The extent of monitoring is determined by a risk-based approach. Per ICH E6, “the purposes of trial monitoring are to verify:

a) The rights 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).

The monitoring service is available to all researchers conducting investigator initiated drug or device trials sponsored by the University of Calgary.

Risk Assessment & Monitoring Plan

The Quality Assurance office will conduct a risk-assessment and, in conjunction with the 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.

Initiation Visit

A study initiation 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:

• Confirmation of subject 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 Visits

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.

CTO monitoring services are offered on a cost recovery basis.  Cost estimates for specific studies will be provided after the monitoring plan has been finalized.

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