Monitoring Clinical Trials

Course Information

Course Code

MCCR140

Instruction Method

Online – login information will be emailed on the course start date

Fee

Domestic: $799 International: $1042

Length

12 weeks – 4.8 CEU

Instructor(s)

Faiza Khawaja

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.

Certificate Program

Clinical Research Program

Topics Covered

• 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.

Instructions to upload proof of COVID vaccination to Self Service


Registration instructions:

  1. Select button “View Available Sections and Registration”
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  3. If you have a Self service account, sign in here. If you do not, then create an account.
  4. Select your course/section by clicking the “Add” button which will send the course to your cart.
  5. To move on to payment, click the blue “Register” button.
  6. Once payment has been processed, registration is complete.