Monitoring Clinical Trials

Course Information

Course Code

MCCR140

Instruction Method

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

Fee

Domestic: $847 International: $1101

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. 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

Certificate Program

Clinical Research Program

Topics Covered

  • Introduction to monitoring
  • Site selection
  • Monitoring plans
  • Monitoring Styles
  • Types of monitoring visits
  • Conducting monitoring visits
  • 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:

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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.