Learner Outcomes

Upon successful completion of the course, the Learner will be able to:

1. Describe monitoring in clinical trials
2. Identify and define the Health Canada and ICH requirements for good clinical site monitoring
3. Define the roles and responsibilities of a monitor as they relate to the quality of clinical trial monitoring
4. Evaluate and identify good clinical sites and investigators
5. Recognize skills to perform successful monitoring to identify any misconduct and how good clinical trial monitoring can impact clinical research outcomes
6. Explain and conduct activities at site evaluation, site initiation, routine monitoring and close-out visits
7. Put into practice the regulatory, source documentation and record-keeping requirements for clinical trials
8. Ensure that data and supporting documentation is accurate for inspectors
9. Identify, assess and validate potentially efficient tools for the implementation of monitoring strategies
10. Discuss and make corrective action plans with multiple monitoring, site, inspection findings and data management issues

Course Objectives

This course provides a solid understanding of Health Canada, FDA, and ICH guidelines for Monitoring Clinical Trials. Students will gain experience in proven techniques for detecting, correcting, and preventing clinical study deficiencies at clinical sites. This course teaches the purpose and ways of monitoring ensuring that data and supporting documentation are entirely accurate, factual and in the appropriate format for sponsors and regulatory authorities. The course work includes practical examples and exercises for reviewing protocols, evaluating consent forms, eCRFs, source documents, Investigator Site File, and writing letters and reports.

Intended For

Healthcare professionals interested in clinical research