As part of the Clinical Research Program, Ethical Issues in Clinical Research (ETCR120) course enables healthcare professionals to understand ethical issues related to research in a clinical setting.

This course provides a solid understanding of Health Canada, FDA, and ICH guidelines for monitoring clinical trials. Learners 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.

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

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