Monitoring Clinical Trials
Online – login information will be emailed on the course start date
Domestic: $799 International: $1042
12 weeks – 4.8 CEU
Upon successful completion of the course, the Learner will be able to:
- Identify and define the principles and requirements for good clinical site monitoring
- Define the roles and responsibilities of sponsor, monitor, investigators and regulatory bodies as they relate to the quality of clinical trial monitoring
- Recognize how good clinical trial monitoring can impact clinical research outcomes
- Put into practice the regulatory, source documentation and record-keeping requirements for clinical trials
- Understand what happens during an FDA and Health Canada inspection
- Ensure that data and supporting documentation are accurate for inspectors
- Identify, assess and validate potentially efficient tools for the implementation of monitoring strategies
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.
Healthcare professionals interested in clinical research
MCCR140 is an elective in the certificate program.
• Monitor role in clinical trial management
• Study preparation from the monitor’s perspective
• Prepare for and conduct monitoring visits
• Source data verification
• Prepare for and plan close out visits
Monitoring Clinical Trials (MCCR140) is part of the Clinical Research Program. This course allows healthcare professionals who are interested in clinical research to develop basic skills necessary to monitor clinical trials.
COVID Vaccine Requirement:
Effective September 7th all learners, faculty and staff must provide proof of at least one-dose of approved COVID-19 vaccine to participate in any in-person learning or on-site activities. Proof of full vaccination will be required as of October 8th, 2021.
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