Learner Outcomes

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

1. Identify and define the principles and requirements for good clinical site monitoring
2. Define the roles and responsibilities of sponsor, monitor, investigators and regulatory bodies as they relate to the quality of clinical trial monitoring
3. Recognize how good clinical trial monitoring can impact clinical research outcomes
4. Put into practice the regulatory, source documentation and record-keeping requirements for clinical trials
5. Understand what happens during an FDA and Health Canada inspection
6. Ensure that data and supporting documentation are accurate for inspectors
7. Identify, assess and validate potentially efficient tools for the implementation of monitoring strategies

Course Objectives

Obtain the basic knowledge and skills necessary to monitor clinical trials in today’s ever changing clinical research environment. This practical course will provide guidance on best practices for selecting investigators, conducting monitoring visits and safety monitoring.

Intended For

Healthcare professionals interested in clinical research

Note:

MCCR140 is an elective in the certificate program.